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.
Cardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures.
For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.
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.
Cardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures.
For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.
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.
Cardiac Science issued an "Urgent - Voluntary Medical Device Correction AED Resistor Issue" letter dated November 13, 2009. Consignees were informed of the affected product and instructed on preventive measures.
For further information, contact Cardiac Science at 1-877-901-1788 in the US and +44-161-926-0011 for outside the US.
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
Water Caloric Irrigator - Product Code ETP
Reason
Some of the filters on both the display board and the main electronic board (pcb) become oxidized causing the lcd display to be garbled and the timer will not operate.
Action
Micromedical Technologies, Inc. sent letters dated November 16, 2009 via e-mail (with read receipt) to each customer and their representative. If they did not have the customer's e-mail address, the sales representative was requested to forward the letter to the customer and copy Micromedical. The letters advised the customers that one or more electronic components in the AquaStar caloric irrigator may fail due to contact corrosion. In the event of this failure, unheated tap water will continue to flow through the device back to the water drain, but the LCD display will be garbled and the timer will not operate. If this problem develops, the account should stop using the irrigator and contact Micromedical Technologies, Inc. at 1-217-483-2122 or via e-mail at mmtinfo@micromedical.com to report the problem for repair of the unit.
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.
Biomet microfixation, inc. is recalling their onpoint tmj kit (part numbers 24-3050, 24-3055) and arthrosimplicity tmj arthocentesis kit (part numbers 922070, 922090, 922075). these two kits contain a bd sterile disposable 60 ml luer-lok syringe, part number 309653 which is under recall by becton dickinson (recall number z-2347-2008). becton dickinson has determined that unit package seal integ.
Action
Consignees were notified by a combination of telephone, fax, e-mail and certified mail.
Questions related to this notice should be directed to Christy Cain at 1-800-874-7711.
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.
Biomet microfixation, inc. is recalling their onpoint tmj kit (part numbers 24-3050, 24-3055) and arthrosimplicity tmj arthocentesis kit (part numbers 922070, 922090, 922075). these two kits contain a bd sterile disposable 60 ml luer-lok syringe, part number 309653 which is under recall by becton dickinson (recall number z-2347-2008). becton dickinson has determined that unit package seal integ.
Action
Consignees were notified by a combination of telephone, fax, e-mail and certified mail.
Questions related to this notice should be directed to Christy Cain at 1-800-874-7711.
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.
Biomet microfixation, inc. is recalling their onpoint tmj kit (part numbers 24-3050, 24-3055) and arthrosimplicity tmj arthocentesis kit (part numbers 922070, 922090, 922075). these two kits contain a bd sterile disposable 60 ml luer-lok syringe, part number 309653 which is under recall by becton dickinson (recall number z-2347-2008). becton dickinson has determined that unit package seal integ.
Action
Consignees were notified by a combination of telephone, fax, e-mail and certified mail.
Questions related to this notice should be directed to Christy Cain at 1-800-874-7711.
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.
Chromagar products are labeled incorrectly. label currently states that the product is for ivd use, when it should state that the product is intended for research use, not for use in diagnostic procedures.
Action
Two recall letters were sent via certified mail to customers. One letter was dated November 9, 2009 referencing the CHROMagar VRE product and the other letter dated November 12, 2009 referencing the CHROMagar 0157 product. The letters describe the affected product, problem, and action to be taken by the customer. The customers are to please STOP the use or distribution of the listed products and IMMEDIATELY examine your stock and return any un-expired CHROMagar product slated for recall for replacement the DRG International, Inc. The customers are being requested to please fill out and return the disposition sheet even if you have none of these items on hand since the information is important.
If you have any questions, please contact customer service at (908) 233-0758.
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.
Chromagar products are labeled incorrectly. label currently states that the product is for ivd use, when it should state that the product is intended for research use, not for use in diagnostic procedures.
Action
Two recall letters were sent via certified mail to customers. One letter was dated November 9, 2009 referencing the CHROMagar VRE product and the other letter dated November 12, 2009 referencing the CHROMagar 0157 product. The letters describe the affected product, problem, and action to be taken by the customer. The customers are to please STOP the use or distribution of the listed products and IMMEDIATELY examine your stock and return any un-expired CHROMagar product slated for recall for replacement the DRG International, Inc. The customers are being requested to please fill out and return the disposition sheet even if you have none of these items on hand since the information is important.
If you have any questions, please contact customer service at (908) 233-0758.
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
ventilator - Product Code CBK
Reason
Some servo ventilators 300/300a and servo ventilator 900c/d/e should not be used with a system that may generate negative pressure below -100 cm h2o (closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
Action
Maquet sent Device Correction letters commencing 11/17/09 and ending 11/23/09 by Federal Express.
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
analyzer, chemistry, centrifugal, for clinical use - Product Code JFY
Reason
Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
Action
An "URGENT: PRODUCT RECALL NOTICE" dated November 16, 2009, was sent to customers. The notification described the product, issue/impact, and the action/resolution to be taken by the customers. The customers are to discontinue use of the specified lot, contact Abaxis for immediate replacement and complete and return the enclosed Response form within 5 working days. They may fax the form to Abaxis Technical Support at 1-510-315-3140. The customer are requested to ensure all laboratory staff are informed about this notice and retain this notification as a part of their laboratory Quality System documentation. The firm is currently contacting all direct shipment customers.
If you have any questions regarding this Product Recall Notice, please contact Abaxis Medical Technical Support at 800-822-2947, extension 6505, or at medtechsupport@abaxis.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
ventilation accessories - Product Code BZD
Reason
Foreign material: glass fragments may present in the plastic bag material used to ship components.
Action
The recalling firm issued a Recall Notification dated 10/18/07 to its customers. Replacement products were to be sent.
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
Patella Cutter - Product Code HTS
Reason
Disposable patella cutters - 30 mm (catalog number 8000-0030, lot v31257001) were packaged and labeled as 33 mm disposable patella cutters (catalog number 8000-0033, lot v31257001 and vice versa.
Action
An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.
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
knee prosthesis implant - Product Code JWH
Reason
The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.
Action
Zimmer sent a recall letter, dated 11/12/09, to each initial consignee on 11/13/09. Zimmer field staff is to remove the product from affected hospitals, and to provide them with a copy of the recall letter.
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
Catheter, biliary, diagnostic - Product Code FGE
Reason
Ev3 has determined that a lot of 150mm prot¿g¿ everflex biliary stent system contains a 100mm length self-expanding stent. the implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention.
Action
Two separate letters were sent to United States and international consignees on November 9, 2009. The letter to US consignees was addressed to Cath Lab Managers while the letter to foreign consignees was addressed to the Risk Manager or Cath Lab Manager. The letters described the affected product, gave an Issue Summary and Required Action, which advised consignees to locate and remove the recalled product. An Ev3, Inc. sales representative will contact consignees to arrange return of all unused product to Ev3, Inc. Direct questions regarding the recall to Ev3, Inc. by calling Customer Service at 1-800-716-6700.
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.
Power cords' prongs may crack or fail -- philips was notified that fda is investigating whether certain types of electri-cord manufacturing company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. potential for burns or electrical shock.
Action
Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside plug. The issue affects medical device power cords equipped with a plug that has a prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug ("taller bridge" design). Medical device power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected. Urgent Medical Device Correction letters were sent to Distributors describing the problem and giving them instructions for notifying customers and actions to be taken. Customers are to visually inspect the affected cords, complete the Customer Reply Power Cord Order Form, and follow the instructions to dispose of affected cords. Further information or support concerning this issue can be obtained by contacting a Philips representative at 1-800-722-9377.
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
Photo Metric Method, Iron (non-heme) - Product Code JIY
Reason
Turbidity formation could occur, resulting in invalid test results being reported out.
Action
Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product.
Please call 1-800-757-5313 if you have questions.
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
Photo Metric Method, Iron (non-heme) - Product Code JIY
Reason
Turbidity formation could occur, resulting in invalid test results being reported out.
Action
Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product.
Please call 1-800-757-5313 if you have questions.
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.
Draeger Medical Systems, Inc. issued and Urgent Medical Device Recall letter dated November 2009 to their affected customers informing them of the problem and a work around until software can be validated. A Technical Service Bulletin has been generated and distributed globally that instructs the affected International Drager subsidiaries to inform customers in their countries.
For further information, contact Draeger Medical Systems, Inc. at 1-800-543-5047, extension 1-2349.
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
Soft Tissue Nondegradable Fixation Fastener - Product Code MBI
Reason
Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
Action
Distributors, hospital consignees and an implanting surgeon were notified of the recall by an Urgent Medical Device Recall Notice, dated 11/10/09. Distributors were instructed to locate and remove the identified products from circulation. The instructions on the enclosed "FAX Back Response Form" should be followed and product from their accounts should be returned. Hospital consignees and the implanting surgeon were informed of the recall and advised of the potential health hazards presented by the mix-up.
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
Soft Tissue Nondegradable Fixation Fastener - Product Code MBI
Reason
Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
Action
Distributors, hospital consignees and an implanting surgeon were notified of the recall by an Urgent Medical Device Recall Notice, dated 11/10/09. Distributors were instructed to locate and remove the identified products from circulation. The instructions on the enclosed "FAX Back Response Form" should be followed and product from their accounts should be returned. Hospital consignees and the implanting surgeon were informed of the recall and advised of the potential health hazards presented by the mix-up.
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
Percutaneous Catheter - Product Code DQY
Reason
Catheter may crack near the radiopaque marker band at the distal end of the device during use. cracking of the catheter shaft in this location can result in material separation, and potential embolization.
Action
Consignees were sent a Medical Device Recall letter, dated 11/6/09. The letter was addressed to Risk Manger or Cath Lab Manage. The letter provided the Issue Summary, identified the Affected Product, and stated the Required Action, which asked consignees to locate and remove the affected product. Questions should be directed to ev3 Customer Service at 800-716-6700.
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
IV Start Bundle Kit - Product Code FPA
Reason
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Action
On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.
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
Venous Access Tray - Product Code FPA
Reason
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Action
On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.
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
dialysis kit - Product Code FPA
Reason
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Action
On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.