Cook recalls Bentson Plus Wire Guide devices with potential packaging seal breaches that could compromise sterility. Affected lots include specific part numbers and serial ranges. Consumers should check their device details against the list provided.
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 Bentson Plus Wire Guide devices that may have a broken packaging seal, risking loss of sterility. This could lead to infections if the devices are used without proper sterilization.
The packaging seal may be completely breached, which could compromise the sterility of the device. If the device is not properly sterilized after the breach, it could lead to infections during medical procedures.
Medical professionals using the Bentson Plus Wire Guide devices for procedures are most at risk. Patients receiving these devices during surgery could be affected if the devices are not sterile.
Check for the part numbers TSFBP-35-180 (GPN G09782) or TSFBP-35-145 (GPN G09735) with specific lot numbers listed in the recall notice. The devices are sold under the brand Cook.
Compare your device's part number and lot number against the list provided in the recall notice to determine if it is affected.
Cook identified that some devices may have a complete breach of the chevron seal of the packaging, which could compromise sterility.
Check your device's part number and lot number against the list provided in the recall notice to see if it is affected. If affected, you should not use the device.
The recall notice does not mention a fix or remedy for this issue.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1825-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1825-2022 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.
