Medline recalls 13 types of sterile stopcocks with potential microscopic pinholes causing non-sterile conditions. Affected models include 200 psi and 400 psi variants with specific lot numbers. Consumers should check their product details and contact Medline for replacement.
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Medline is recalling 13 different sterile stopcock products due to microscopic pinholes that could breach the sterile barrier. This risk may lead to non-sterile conditions during medical procedures. The recall affects specific models and lot numbers sold between December 2023 and July 2024.
The stopcocks may have microscopic pinholes in the sterile pouch, which could allow non-sterile conditions to occur during medical procedures. This is a risk for sterile environments where contamination could lead to infections.
Healthcare professionals and medical facilities using these stopcocks for procedures. The risk is low as the pinholes are microscopic and unlikely to cause immediate harm.
Check for the product model numbers (REF 70015002 to 70055017) and lot numbers listed in the recall notice. Products were sold between December 31, 2023, and July 12, 2024.
Review the product model and lot numbers to confirm if your stopcock is affected. The recall includes specific REF and UPN numbers with listed lot ranges.
The recall states there is a potential for microscopic pinholes that could breach the sterile barrier, but the risk is low and not all products are affected.
Check the product model (REF) and lot numbers listed in the recall notice. Affected models include REF 70015002 to 70055017 with specific lot ranges provided.
The recall does not require immediate stoppage; the risk is low and the remedy is not specified in the notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2575-2021 — Medline Medline Hello, I own a Medline that is covered by recall Z-2575-2021 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.
