Recall Z-2454-2024 ยท DQO Catheter, Intravascular, Diagnostic
Angiodynamics, Inc.
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
| Date | Jul 31, 2024 (initiated Jun 18, 2024) |
| Status | Open, Classified |
| Reason | Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length) |
| Root cause | Packaging change control |
| Action | Angiodynmaics issued Urgent Medical Device Recall Letter on 6/18/24 via Federal Express to end-users. Letter states reason for recall, health risk and action to take: " IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification T |
| Quantity | 595 boxes |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters AngioDynamics, Inc., Jul 18, 2018 |