Cook recalls Peel-Away Introdu: Packaging may have low seal strength, risking device sterility. Affected units sold with specific part numbers. Stop using immediately if you own the recalled model.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Cook is recalling Peel-Away Introducers due to packaging that may not seal properly, which could compromise the device's sterility. This means the medical device might not be clean enough for safe use, potentially causing infections.
The packaging may have low seal strength, meaning it might not hold the device sterile during use. If the packaging fails, the device could become contaminated, increasing infection risk during medical procedures.
Medical professionals and patients who use the Peel-Away Introducer for catheter procedures. Those with the specific part numbers listed in the recall are most at risk.
Check for part numbers PLVW-7.0-35 (G00925) or PLVW-8.0-35 (G01844) on the packaging. The recall covers units sold with these specific part numbers.
Look for part numbers PLVW-7.0-35 (G00925) or PLVW-8.0-35 (G01844) on the packaging to identify affected units.
The packaging may have low seal strength, which could compromise device sterility during medical procedures.
Part numbers PLVW-7.0-35 (G00925) and PLVW-8.0-35 (G01844) are affected.
The recall does not specify a stop-use action, but you should check if your unit is affected before use.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1528-2024 — Cook Cook Hello, I own a Cook that is covered by recall Z-1528-2024 from Cook. 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.
