Cook recalls specific Fixed Core Wire Guide (Safe-T-J Curved) models due to potential packaging sterility breach. Affected items may not be sterile, risking infection during medical procedures. Check part numbers and expiration dates listed.
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 certain Fixed Core Wire Guides (Safe-T-J Curved) because the packaging may have a complete breach in the chevron seal. This could compromise the sterility of the devices, making them unsafe for medical procedures. Affected items have specific part numbers and expiration dates.
The chevron seal on the packaging may be completely breached, which could allow contamination. This means the devices might not be sterile when used in medical procedures, increasing the risk of infection for patients.
Medical professionals using these devices for procedures are most at risk. Patients receiving these devices could face infection if the devices are not sterile.
Check for part numbers starting with TSCF-25-180-3, TSCF-35-180-3, or other listed codes. The expiration dates range from June 2027 to July 2027. The UDI-DI codes are also listed in the recall notice.
Look for part numbers like TSCF-25-180-3 G01602 or TSCF-35-180-3 G00902 on the device packaging.
Ensure the expiration date matches the listed dates (June 2027 to July 2027) for affected items.
Cook identified that some devices may have a complete breach in the chevron seal of the packaging, which could compromise sterility.
Check the part number and expiration date against the list provided in the recall notice. Affected devices have specific part numbers and expiration dates listed.
No action is needed if your device does not match the part numbers or expiration dates listed in the recall.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1833-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1833-2022 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.
