Medline recalls Venclose Procedure Packs with incorrect 12cm sheath instead of 7cm. This could cause complications during cardiovascular procedures. Affected units include specific model numbers and lot dates.
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
Medline is recalling Venclose Procedure Packs that have a 12cm introducer/sheath instead of the correct 7cm size. Using these packs during cardiovascular procedures could lead to complications due to the incorrect size.
The recalled kits contain a 12cm introducer/sheath component instead of the required 7cm size. This incorrect size could cause improper insertion during procedures, potentially leading to complications like vessel damage or bleeding.
Healthcare professionals using the Venclose Procedure Packs for cardiovascular procedures are most at risk. Patients undergoing these procedures with the recalled kits may face complications.
Check for model number 7VM with reference code VC-PPH-67A. Look for lot numbers 22EBV345 or 22FBF358, both expiring August 31, 2024.
Verify the model number and lot numbers listed in the recall notice to confirm if your kit is affected.
The correct size is 7cm (component #137340 - SET INTRO 6.5FX7CM FITS 0.018).
The recall notice does not specify a remedy, so contact Medline directly for guidance.
The recall was issued with the provided details but the exact date is not stated in the record.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0088-2023 — Medline Medline Hello, I own a Medline that is covered by recall Z-0088-2023 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
