Recall Z-0590-2012 ยท MSD Catheter, Hemodialysis, Implanted
Angiodynamics, Inc.
DURAMAX 15.5 F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraMax Stacked Tip 36 cm Str. Basic Kit, Catalog No./REF 10302806, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY 12804 USA The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
| Date | Jan 11, 2012 (initiated Jan 24, 2011) |
| Status | Terminated |
| Reason | AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, AngioDynamics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 28, 2011 and response form via Certified Mail, Return Receipt Requested, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to identify and segregate the recalled lots; complete and return the enclosed DuraMax HemoDialysis Catheter Recall Reply Form via fax to: Attn: DuraMax HemoDialysis Catheter Recall Coordinator at 518-798-1360 (even if they don't have any product); and do not use the affected product, return and ship the recalled product to |
| Quantity | 39 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |