Cook recalls Bentson Wire Guide devices with potential packaging seal breaches that could compromise sterility. Affected units sold only in OUS (outside US) with specific part numbers and expiration dates.
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 Wire Guide devices that may have packaging seals that don't seal properly. This could mean the devices aren't sterile when they should be, which is dangerous for medical procedures.
The packaging seal on these devices might not close properly, which could let contaminants get inside the sterile packaging. This means the devices might not be sterile when they're supposed to be, making them unsafe for medical procedures.
Medical device users in countries outside the US who bought Bentson Wire Guides with the reference part number TSMB-35-145 and expiration date 16-06-2027 are affected. Patients using these devices during surgery could be at risk if the devices aren't sterile.
Check for the reference part number TSMB-35-145 (GPN G27041) on the device packaging. Devices sold outside the US with expiration date 16-06-2027 are affected.
Look for the reference part number TSMB-35-145 (GPN G27041) and expiration date 16-06-2027 on the packaging.
No, this recall applies only to devices sold outside the US (OUS).
The devices might not be sterile, which could cause infections during medical procedures.
Check for the reference part number TSMB-35-145 (GPN G27041) and expiration date 16-06-2027 on the packaging.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1826-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1826-2022 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.
