Home / Recalls / Medical Devices
MEDLINE INDUSTRIES, LP - Northfield recalls VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Recalled October 19, 2022 · FDA recall Z-0088-2023 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
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 · FDA Class II
Units
1760 kits
Sold at
CA
Description
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
Product
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →