Z-0088-2023 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2022
- Initiation Date
- September 1, 2022
- Termination Date
- January 26, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1760 kits
Product Description
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Reason for Recall
Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component #137339 - SET INTRO 6.5FX12CM FITS 0.018, instead of a 7cm introducer/sheath, component #137340 - SET INTRO 6.5FX7CM FITS 0.018
Distribution Pattern
CA
Code Information
UDI/DI 40193489423090, lot number 22EBV345, exp. 08/31/2024; UDI/DI 10193489423099, lot number 22FBF358, exp. 08/31/2024