Cook recalls stainless steel wire guides with potential packaging seal breaches that could compromise sterility. Affected models include PMG-18SP-60-COPE G05183 and others with specific lot numbers. Consumers should check their device's serial code and expiration date.
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 certain stainless steel wire guides due to possible breaches in the packaging seal. This could mean the devices are no longer sterile, which is dangerous for medical procedures. Affected items have specific lot numbers and expiration dates listed in the recall notice.
The packaging seal may be completely broken, which means the devices might not be sterile when they reach the user. In medical procedures, using non-sterile devices can lead to infections or other complications.
Medical professionals using these wire guides for procedures are most at risk. Patients receiving these devices during surgery could be exposed to infection if the devices are not sterile.
Check the device's reference part number (GPN) and lot number. Affected items include PMG-18SP-60-COPE G05183 with specific lot numbers like 14795012 and expiration dates from June 15, 2027, through July 14, 2027.
Look for the reference part number (GPN) and lot number on the device packaging or label.
Cook identified that some devices may have a complete breach of the chevron seal in the packaging, which could compromise sterility.
The recall notice does not specify a remedy, so you should check the device's reference part number and lot number to see if it's affected.
Yes, affected models include PMG-18SP-60-COPE G05183, PMG-18SP-100-COPE G05822, and PMG-18SP-125-COPE G10077 with specific lot numbers and expiration dates.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1830-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1830-2022 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.
