Cook recalls Rosen Curved Wire Guides with specific part numbers and expiration dates due to potential packaging seal breaches that could compromise sterility. Affected units may not be sterile, risking infection during medical procedures.
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 Rosen Curved Wire Guides with certain part numbers and expiration dates because the packaging seal might be completely broken. This could mean the medical devices aren't sterile anymore, which is dangerous during surgeries or medical treatments.
The packaging seal on the devices might be completely broken, which could mean the devices aren't sterile anymore. If the devices aren't sterile, they could cause infections during medical procedures.
Medical professionals using these devices for procedures like surgery or medical treatments. Patients undergoing procedures with these devices are at risk if the devices aren't sterile.
Check for part numbers THSCF-35-220-1.5-ROSEN G01623, THSCF-35-80-1.5-ROSEN G01774, THSCF-35-180-1.5-ROSEN G01264, or THSCF-35-145-1.5-ROSEN G01261. Also look for expiration dates from June 29, 2027 through July 20, 2027.
Look for the part numbers and expiration dates listed in the recall notice to confirm if your device is affected.
Cook Medical identified that devices from the affected lots may have a complete breach of the chevron seal of the packaging, which could compromise sterility.
The affected part numbers are THSCF-35-220-1.5-ROSEN G01623, THSCF-35-80-1.5-ROSEN G01774, THSCF-35-180-1.5-ROSEN G01264, and THSCF-35-145-1.5-ROSEN G01261.
Check for the specific part numbers and expiration dates listed in the recall notice, which range from June 29, 2027 through July 20, 2027.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1842-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1842-2022 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.
