Device product

VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.

Z-0088-2023

September 01, 2022

Class II

Product summary

Firm: MEDLINE INDUSTRIES, LP - Northfield
Event: Event 90889
Status: Terminated
Classification: Class II
Quantity: 1760 kits
Official record key: device-enforcement:Z-0088-2023

Official wording

Reason: 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

Code information: UDI/DI 40193489423090, lot number 22EBV345, exp. 08/31/2024; UDI/DI 10193489423099, lot number 22FBF358, exp. 08/31/2024

Distribution pattern: CA

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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