Cook recalls dilators with AQ hydrophilic coating due to potential packaging issues that could compromise device sterility. Affected models include JCD10.0-38-20-HC and others with specific reference numbers.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Cook is recalling dilators with AQ hydrophilic coating because the packaging might not seal properly, risking contamination. This could lead to infections if the device is used without proper sterility.
The packaging may have low seal strength, which could allow contaminants to enter the device. This might compromise the sterility of the device during medical procedures, increasing infection risk.
Healthcare professionals using these dilators for medical procedures are most at risk. Patients receiving these devices during procedures may also be affected if sterility is compromised.
Check for reference part numbers like JCD10.0-38-20-HC or order numbers such as G10207. The specific lot numbers and UDI-DI codes are listed in the recall notice.
Review the reference part numbers and lot numbers provided in the recall notice to confirm if your device is affected.
The packaging may have low seal strength, which could compromise device sterility during medical procedures.
Dilators with reference part numbers JCD10.0-38-20-HC, JCD14.0-38-20-HC, JCD16.0-38-20-HC, JCD6.0-38-20-HC, and JCD8.0-38-20-HC are affected.
No action is required beyond checking if your device matches the reference numbers listed 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-1531-2024 — Cook Cook Hello, I own a Cook that is covered by recall Z-1531-2024 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.
