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.
Notas adicionales en la data
Surgical Tray - Product Code LRP
Causa
Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. the actual roc bolts themselves are correctly laser etched.
Acción
Alphatec contacted consignees via phone on December 16, 2008 and informed consignees that they will arrange to have Federal Express contact them for pick-up.
Consignees were asked to check their inventory to see where this product is located, and ensure that it is put on hold for return; and what days and hours they are in the office, (Confirm address: attach copy of the pick-up request form.)
If they have any follow up questions, they were told to call 1-800-922-1356.
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.
Notas adicionales en la data
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Causa
The product may contain an incorrect size catheter and introducer.
Acción
Notification of the AngioDynamics, Inc. sales force began on July 16, 2009 and they were asked to assist in the return of all affected devices to the Manchester, GA division of AngioDynamics, Inc. Urgent Recall letters were sent to all customers on July 16, 2009, requesting the completion of a FAX BACK form. Those currently in possession of any remaining devices will be provided a Return Goods Authorization (RGA) number and pre-paid shipping boxes for return of the product to AngioDynamics, Inc. All returned devices will be physically and electronically quarantined until final disposition of the devices. All devices will be inspected for damage to the devices and any damaged devices destroyed (scrapped) via the AngioDynamics procedure for Disposition of Nonconformances, procedure. Non-damaged product may be reworked to remove the incorrect catheter and introducer and replaced with the correct catheter and introducer, repackaged and re-sterilized in accordance with the AngioDynamics procedure for Rework. If necessary, follow-up letters, phone calls or visits by the AngioDynamics sales representatives may be used to complete the effective checks. Level A (100%) of consignees to be contacted).
Please contact your local representative or Recall Coordinator at 1-706-846-3126, for assistance. You may e-mail your questions to customerservice@angiodynamics.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.
Surgical tables were produced using an unapproved tilt frame bushing.
Acción
Stryker Communications issued an "Urgent: Medical Device Recall" notice dated November 13, 2008 informing Consignees of the affected product. The firm intends to contact each facility to coordinate service by a trained representative.
For further information, contact Stryker at 1-972-410-7100.
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.
Notas adicionales en la data
Generator, oxygen, portable - Product Code CAW
Causa
The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.
Acción
Cobham Life Support Systems, Inc. issued letters to their two customers via e-mail. One customer letter was dated July 24, 2009 and the other was dated July 28, 2009. Both letters notified the customer of the reason for the recall and that the usage of the concentrator must be restricted to exclude actual use with a patient until corrected. The letter informs customers they are redesigning the backup supply control valve and will coordinate the retrofit in the future.
For further information, contact Cobham Life Support at 1-563-383-6421.
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.
Notas adicionales en la data
Pyxis Anesthesia System 3500 - Product Code BRY
Causa
Cardinal health has sent out a safety alert notification to inform its customers that the sr2b software for the pyxis anesthesia system 3500 (pas 3500) has received several customer reports of system "non-responsiveness" (lock ups) during the use of the product since its release in september 2008.
Acción
The "Safety Alert Notification" letter was mailed to all Pyxis Anesthesia System 3500 customers on December 17, 2008 by registered return receipt mail. The letter was addressed to the Director of Pharmacy at each facility. The mailing packages contain the "Safety Alert Notification" letter and the revised pages of the Pyxis Anesthesia System 3500 User Guide and Safety Manual. The "Safety Alert Notification" letter reinforced to customers how to maintain back-up processes to allow quick access if a system lock-up condition is experienced.
The letter informed customers the situation will be corrected and a solution will be implemented. If you experience any system unresponsiveness during the use of the product, please report the issue to the Cardinal Health Technical Support Center at 1-800-727-4102. If you have any questions regarding this issue, please contact your local field support representative or the Customer Advocacy Department at Customer.Advocacy@cardinalhealth.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.
Notas adicionales en la data
Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
Causa
The peritoneal dialysis transfer set has a defective white sleeve twist clamp. the twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.
Acción
Baxter Healthcare Corporation telephoned the accounts receiving the affected lots and then faxed or e-mailed "Urgent Product Recall" letters dated July 2, 2009, to them, to the attention of the Peritoneal Dialysis Nurse, to inform them of the defective white sleeve twist clamp, which may result in leakage and possible peritonitis. The accounts were asked to immediately discontinue the use of the affected lot numbers and examine their inventory for the affected lots. If any affected product was found, they were requested to quarantine it and contact Baxter Center for Service at 1-888-229-0001 to arrange for its return to Baxter. The accounts were also requested to review their patient records to determine if any of their patients had received the affected product. If so, they were advised to contact the patients to see if they had experienced any leaking. If so, the patients should return to the facility to have the set changed per the facility's transfer set change procedure. Any questions were directed to the Center for One Baxter at 1-800-422-9837, Monday through Friday, 8:00 a.m. to 5:00 p.m. Central Standard Time (CST). The accounts were requested to complete the enclosed reply form acknowledging receipt of the letter and that they followed the instructions and disseminated the information to their staff.
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 sterility may be compromised due to lack of package integrity.
Acción
Davol issued a Recall Letter dated July 30, 2009 requesting user facilities examine inventory and immediately discontinue use of any product from the affected lot and return it to Davol. Direct questions about the recall to Davol, Inc., Sub. C. R. Bard, Inc. by calling 1-401-463-7000.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Retractor - Product Code GAD
Causa
Sterility of device compromised due to breach in packaging.
Acción
Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.
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.
Notas adicionales en la data
Hip Joint Femoral (hemi-hip) Metal/Polymer Cemented or Uncemented Prosthesis - Product Code KWY
Causa
The apex hip system bipolar head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Acción
Omni Life Science notified distributors and implanting surgeons by an Urgent, APEX Hip System Bipolar Head Voluntary Recall letter dated June 29, 2009. The method of notification is both e-mail and FedEx overnight. The letter requires a signature acknowledging receiving the letter and the letter is to be faxed back to Omni Life Science. The Distributors/Sale Representatives are instructed to fill in the "Quantity Returned" on the recall letter and fax back to Omni. They are to ship all existing Apex Hip System Bipolar Head inventory by 07/10/2009 to the directed address.