Recall Z-2397-2008

Reason for recall

The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site.

FDA-determined cause: Process design

Action taken

AngioDynamics sent URGENT MEDICAL DEVICE letters and reply forms to the consignees via Certified Mail on/about 7/10/08. The recall is being conducted to the medical user level. AngioDynamics is requesting the return of all Centros Hemodialysis Catheters in inventory. The following steps should be taken by the consignees: 1. Identify and segregate the recalled product that is in your possession. 2. Complete the enclosed Centros Hemodialysis Catheter Recall Reply Form and fax it to the attention of the Centros Recall Coordinator at 518-798-1360. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to AngioDynamics. 3. Ship the recalled product(s) to AngioDynamics. Consignees will be credited for the returned products. Credits will only be issued for returned product that is within the scope of the recall. Reference Return Authorization Number ___ on the outside of the shipping box and include a copy of the Centros Recall Reply Form with the return shipment. --- The letters also provide actions to be taken for product(s) in use: ANGIODYNAMICS recommends that physicians continue to follow facility protocols for inserting dialysis catheters and monitoring dialysis catheter patients. It is recommended that physicians consider evaluation of patients with an indwelling Centros catheter to assure the catheter is properly secured. As stated in the product's instructions for use, it is recommended that the catheter be secured/sutured for the entire duration of implantation. If the sutures have been cut, consider re-suturing to maintain proper catheter position. Do not rely on ingrowth of the cuff to maintain proper catheter position. This failure does not affect the function or integrity of the catheter itself and there have no reports of patient injury due to this problem. For questions, concerns, or more detailed instructions on how to