Cook recalls Bentson Wire Guides with potential packaging seal breaches that could compromise sterility. Affected units include specific model numbers and production lots. 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 Bentson Wire Guides that may have packaging seals that are completely breached, which could compromise the sterility of the devices. This means the devices might not be sterile when used, posing a risk of infection during medical procedures.
The packaging seal on the device may be completely breached, meaning the device might not be sterile when it reaches the user. This could lead to infections during medical procedures if the device is used without proper sterility.
Medical professionals who use these devices during procedures are most at risk. Patients receiving procedures with affected devices could face infection risks.
Check for the model numbers TSFB-35-80 (GPN G01315), TSFB-35-145 (GPN G00691), or TSFB-35-200 (GPN G01095). The affected units have specific production lots and expiration dates listed in the recall notice.
Review the model number and lot information on your device to see if it matches the affected units listed in the recall.
Cook identified that devices from certain lots may have a complete breach of the chevron seal of the packaging, which could compromise sterility.
Check your device's model number and lot information against the affected units listed in the recall notice to determine if it is impacted.
Using a device with a compromised sterility seal could lead to infections during medical procedures.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1827-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1827-2022 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.
