Product Safety Recalls

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MEDLINE INDUSTRIES, LP – Northfield Recall 90889

Page Last Updated: November 19, 2022

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

MEDLINE INDUSTRIES, LP – Northfield Recall 90889 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0088-2023
Event ID90889
Event DescriptionVENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Product TypeDevices
DistributionCA
Quantity1760 kits
Recall ReasonImpacted 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
Device Classification20221019
Device Code InfoUDI/DI 40193489423090, lot number 22EBV345, exp. 08/31/2024; UDI/DI 10193489423099, lot number 22FBF358, exp. 08/31/2024
Center Classification Date20221013
Recall Initiation Date20220901
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
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