CLASS II Device recall · Reported 19 Oct 2022 · FDA Enforcement Report

Venclose, Venclose Procedure Pack, 7vm recalled

Medline Industries LP - Northfield is recalling Venclose, Venclose Procedure Pack, 7vm, distributed in California. The recall was initiated on 1 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 40193489423090, lot number 22EBV345, exp. 08/31/2024; UDI/DI 10193489423099, lot number 22FBF358, exp. 08/31/2024

Quantity recalled1760 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0088-2023
FDA event ID: 90889
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 1 Sep 2022
FDA classified: 13 Oct 2022
Reported: 19 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

1 Sep 2022	Recall initiated by company
13 Oct 2022	Classified by FDA	+42 days
19 Oct 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

California

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medline Industries LP - Northfield

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