Cook recalls certain Double Flexible Tipped Wire Guide devices due to potential packaging seal breaches that could compromise sterility. Affected units include specific part numbers and expiration dates. Consumers should check their product details to determine if they are impacted.
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 Double Flexible Tipped Wire Guide devices because the packaging may have a complete breach in the chevron seal. This could mean the devices are no longer sterile, which is dangerous for medical procedures.
The chevron seal on the packaging may be completely breached, which 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 using these devices for procedures are most at risk. Patients receiving these devices during surgery could be affected if the devices are not sterile.
Check for part numbers TDOC-35-145-0-3 G00362, C-TDOC-18-50-0-2 G05146, or other listed model numbers. The expiration dates range from June 14, 2027, to June 29, 2027.
Look for the part numbers and expiration dates listed in the recall notice to determine if your device is affected.
Cook identified that devices from certain lots may have a complete breach of the chevron seal, which could compromise sterility.
Check for part numbers like TDOC-35-145-0-3 G00362 or expiration dates from June 14, 2027, to June 29, 2027.
The recall notice does not specify a remedy, so contact Cook directly for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1831-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1831-2022 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.
