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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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
Blood access device and accessories - Product Code MSD
Reason
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. if this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. a second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira.
Action
Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical Customer Service at 1-877-876-8635.
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.
Certain models of powerheart g3 aeds may not have received adequate electrical safety testing prior to being shipped from the factory. affected models are: powerheart 9300a, 9300c, 9300d, 9300e, 9300p, 9390a, 9390e, cardiovive 92532, 92533, nk 9200g, 9231, and responder 2019198 and 2023440. the affected devices were manufactured between october 29, 2003 and february 10, 2009.
Action
Cardiac Science issued "Urgent - Medical Device Corrective Action" notices dated October 2009. Customers were instructed to identify the affected product and arrange for product replacement with the firm. Where possible, end user information was requested for further follow-up by the firm.
For further information, contact Cardiac Science at 1-877-402-4599 or by email at AED155@cardiacscience. 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.
Extra notes in the data
Manual Pulmonary Resuscitator - Product Code BTM
Reason
In some manual pulmonary resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the mpr bag/body. if this occurs, the mpr may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Action
Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product.
Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.
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.
Amended reason for recall: the piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for e. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for k. pneumoniae.
Action
bioMerieux issued a "Product Correction Notice" letter dated September 13, 2010, to their entire customer base (regardless of whether they ever ordered the recalled cards). The letters explained the reason for the recall and instructed the account to confirm all results for E. coli using a second method, and for K. pneumoniae, to confirm with a second method only for resistant results. These alternate test confirmations are to continue until further notice. The customers were to complete and return the enclosed Acknowledgement Form via fax at (314) 731-8689 or (919) 620-6350 which indicate that the notice has been read, the instructions provided in the "Actions Required" section were followed, and notes if they have received any reports of illness or injury related to this issue. All future shipments will include an orange multilanguage insert to go into the boxes reminding customers they must perform an alternate test for TZP/E. coli combinations and that customers must also perform an alternate method prior to reporting TZP results when a resistant result is obtained for the TZP/K. pneumoniae. Additionally, this recall letter will accompany shipments of instrument software kits for the new customers.
The recalling firm issued a press release on 10/27/10 via the Associated Press notifying the public of the recall.
The recalling firm expanded their recall to add 7 more organisms to the list of organism testing that were to be suppressed. As a result the recalling firm issued a letter dated 3/30/11 via Fed Ex on 4/4/11 flagged "URGENT PRODUCT CORRECTION NOTICE (EXPANDED RECALL), VITEK 2 Piperacillin/Tazobactam Test, Document #9300786." The letter describes the issues, how the issues impact the test results, describes the product changes that are going to take place, and provides instructions on required actions to be taken.
The product changes will involve the eventual changeover to new cards that will be created which do not contain Piperacillin/Taz
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
Manual Pulmonary Resuscitator - Product Code BTM
Reason
In some manual pulmonary resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the mpr bag/body. if this occurs, the mpr may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Action
Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product.
Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.
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
Manual Pulmonary Resuscitator - Product Code BTM
Reason
In some manual pulmonary resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the mpr bag/body. if this occurs, the mpr may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
Action
Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product.
Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.
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.
Product monitoring has determined that the connection bracket shows potential mechanical play at the or table interface for some procedures. this is due to the hole in the lock washer, which is responsible for locking the accessory to the or table, being too large.
Action
Urgent Device Correction Letters were sent by Federal Express to affected US hospitals on October 22, 2009. The letter stated the technical description, potential hazard, and the recommended precaution. The letter asked customers to immediately verify whether their Connection Bracket is affected thru the FaxBack provided. Questions or need for additional information can be directed to customers' local MAQUET representative.
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.
Multiple software-related malfunctions may occur. the device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.
Action
The firm issued a press release on 11/4/09. Consignees were notified by an Urgent: Medical Device Recall Notification letter dated 10/23/09, which advised of the affected products, the reason for the recall, the recall plan, and the actions to be taken. Customers were to immediately review this notification and distribute to all departments affected. Also, customers were to immediately quarantine any affected product and label as recalled product; complete and sign the enclosed Business Reply Form and fax a copy to 866-521-2762. Upon receipt of the form, a Stryker Navigation Field Service Rep would contact them to schedule the repair of their equipment. All U.S. units were corrected by 10/30/09.
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
spinal implant component - Product Code KWQ
Reason
Surgeons may apply an accidental axial torque to and/or over-angulate the all-in one guide while implanting the screw. this may cause the screw not to seat properly in the locking ring and may cause the thor screwdrivers to twist or break at the tip.
Action
Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.