Recall Z-1335-2024 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
Angiodynamics, Inc.
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
| Date | Mar 21, 2024 (initiated Jan 30, 2024) |
| Status | Open, Classified |
| Reason | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case |
| Root cause | Process control |
| Action | AngioDynamics initiated Urgent Voluntary Medical Device Recall Notification packets by Federal Express to consignees on 1/30/24. 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). Mark affected items with text QUARANTINE to segregate from usable stock. o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all |
| Quantity | 4366 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132713 | NMI COAXIAL MICROINTRODUCER SET Navilyst Medical, Inc., Sep 27, 2013 |