Recall Z-1344-2016 ยท OEZ Cardiovascular Procedure Kit
AngioDynamics Inc.
NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
| Date | Apr 7, 2016 (initiated Nov 3, 2015) |
| Status | Terminated |
| Reason | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036". |
| Root cause | Process control |
| Action | On November 03, 2015, Navilyst Medical distributed Urgent Voluntary Medical Device Recall notices to their customers via courier service. Customers were advised to immediately remove the recall product from inventory and to segregate the products in a secure location for return to AngioDynamics, Inc. Customers should immediately forward a copy of the recall notification letter to all sites if these products were further distributed. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday |
| Quantity | 100 kits |
| Distribution | US Nationwide in the states of CA, IL, MA, SC, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.