Cook recalls specific dilator models due to packaging with low seal strength, risking device sterility. Affected units include certain lot numbers for JCD10.0-38-20, JCD20.0-38-20, and other models.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Cook is recalling specific dilator models that may have packaging with low seal strength, which could compromise device sterility. This means the medical device might not be sterile when used, increasing infection risk during procedures.
The packaging may not seal properly, which could allow contamination of the device. This might lead to infections if the device is not sterile when used during medical procedures.
Medical professionals and patients using the recalled dilators for vascular or non-vascular procedures. Those most at risk are individuals who have received the specific lot numbers listed in the recall.
Check the model numbers (JCD10.0-38-20, JCD20.0-38-20, JCD22.0-38-20, JCD6.0-38-15, JCD8.0-38-15, JCD8.0-38-20) and lot numbers listed in the recall notice. The affected units include specific lot numbers for each model.
Identify the model number and lot number on the packaging to see if it matches the recalled units.
Reach out to Cook Incorporated for further assistance if you have the recalled model and lot numbers.
The packaging may have low seal strength, which could compromise device sterility and increase infection risk during medical procedures.
The affected models include JCD10.0-38-20, JCD20.0-38-20, JCD22.0-38-20, JCD6.0-38-15, JCD8.0-38-15, and JCD8.0-38-20 with specific lot numbers listed in the recall.
Check the model number and lot number on the packaging against the list provided in the recall notice.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1530-2024 — Cook Cook Hello, I own a Cook that is covered by recall Z-1530-2024 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.
