Recall Z-1765-2010 ยท MSD Catheter, Hemodialysis, Implanted
Angiodynamics, Inc.
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 36 cm Straight Basic Kit, Catalog Number/REF 10302806, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
| Date | Jun 4, 2010 (initiated Jan 8, 2010) |
| Status | Terminated |
| Reason | The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers were used during the manufacturing 100% leak test. |
| Root cause | Other |
| Action | Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446. |
| Quantity | 52 |
| Distribution | Nationwide and St. Thomas, VI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.