FDA-Device2022-10-19Class II
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
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
Sold states
CA
Affected count
1760 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0088-2023Don't want to check this manually?
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