Angiodynamics DuraMax 15.5F x 40cm Chronic Hemodialysis Catheter Set (with Cuff 35cm from Tip) --- Catalog No. [REF] 103
FDA device recall Z-0723-2012 · posted 2012-01-12 · Terminated
Recall details
- Recalling firm
- Angiodynamics Worldwide Headquarters
- Reason for recall
- The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
- Action taken
- 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. For questions contact your local representative or call the Customer Service Manger at ANGIODYNAMICS Customer Service at 1-800-772-6446.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 50 units
- Distribution
- Worldwide Distribution - USA (Nationwide)
- Date initiated
- 2011-12-30
- Date posted
- 2012-01-12
- Date terminated
- 2016-02-10
- Location
- Latham, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT (K101843) | AngioDynamics, Inc. | 2010-10-20 |