Cook recalls specific Cope Mandril Wire Guide models due to potential packaging seal breaches that could compromise device sterility. Affected items include certain lot numbers with expiration dates through July 2027.
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Cook is recalling specific models of Cope Mandril Wire Guide (Nitinol) devices because the packaging may have a complete breach of the chevron seal. This could mean the devices are no longer sterile, which is critical for medical use.
The packaging seal breach could compromise the sterility of the devices. If the devices are not sterile, they could cause infections or other complications during medical procedures.
Medical professionals who use these devices during procedures are most at risk. Patients receiving these devices could be affected if the devices are not sterile.
Check for the reference part numbers PMG-18SP-60-COPE-NT-ST G09395, PMG-18SP-100-COPE-NT G08687, or PMG-18SP-60-COPE-NT G08427. These devices were sold with specific lot numbers and expiration dates through July 2027.
Look for the reference part numbers and lot numbers listed in the recall notice to determine if your device is affected.
Cook identified that some devices may have a complete breach of the chevron seal, which could compromise sterility.
If your device has a packaging seal breach, it may not be sterile, which could lead to infections during medical procedures.
Check for the reference part numbers PMG-18SP-60-COPE-NT-ST G09395, PMG-18SP-100-COPE-NT G08687, or PMG-18SP-60-COPE-NT G08427 with specific lot numbers and expiration dates through July 2027.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1829-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1829-2022 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.
