Device product
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Z-1329-2021
Product summary
- Firm
- Oscor, Inc.
- Event
- Event 87562
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 devices
- Official record key
device-enforcement:Z-1329-2021
Official wording
Reason: Potential for open seal on sterile product
Code information: GUDID: 25051684026298; Lot Number DP-11759
Distribution pattern: US Nationwide distribution in the state of New York.
Derived failure modes
-
Labeling or packaging
open seal