U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Photometric method, magnesium - Product Code JGJ
Reason
According to the firm, carry over was observed when the amylase or pancreatic amylase test is run directly before or after the magnesium assay. an update is required to the rx imola analyser running order and an acid wash recommended when setting up the magnesium assay. a correction was made to the ifu for the magnesium assay and all rx imola customers in the usa were contacted with the updated instruction.
Action
Randox sent an Urgent Field Safety Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review and update Rx Imola running order where required. Rework any remaining stock with updated IFU and Important Notice. Complete and return the vigilance response section of the form to technicalservikces@randox.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Action
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.