Recall Z-0733-2012 ยท MSD Catheter, Hemodialysis, Implanted
Angiodynamics Worldwide Headquarters
Angiodynamics DuraMax 55 cm STRAIGHT --- 1-15.5F x 55cm DuraMax Hemodialysis Catheter (with Cuff 50cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302909 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY USA 12804 Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis.
| Date | Jan 12, 2012 (initiated Dec 30, 2011) |
| Status | Terminated |
| Reason | The securement cuff on the hemodialysis catheter has the potential to detach from the shaft. |
| Root cause | Nonconforming Material/Component |
| Action | AngioDynamics sent an Urgent - Medical Device Recall letter dated December 30, 2011, via certified mail to all affected customers. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to examine inventory, segregate the recalled lots and return remaining inventory to the firm. The letter states that replacement product will be shipped upon receipt and confirmation of the returned product. Customers were advised to complete the Recall Reply Form included and fax to DuraMax Hemodialysis Catheter Recall Coordinator at 518-798-1360. |
| Quantity | 21 units |
| Distribution | Worldwide Distribution - USA (Nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101843 | DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc., Oct 20, 2010 |