Recall Z-1329-2021 ยท DYB Introducer, Catheter
Oscor, Inc.
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
| Date | Mar 10, 2021 |
| Status | Terminated |
| Reason | Potential for open seal on sterile product |
| Root cause | Under Investigation by firm |
| Action | The firm notified their sole consignee of the recall by letter on 03/23/2021 as a written follow-up communication held on 03/10/2021 which requested the return of the recalled product. |
| Quantity | 500 devices |
| Distribution | US Nationwide distribution in the state of New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.