Cook recalls Torq-Flex Wire Guide Australian Modification devices with potential packaging seal breaches that could compromise sterility. Affected units include specific part numbers and production lots.
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 Torq-Flex Wire Guide Australian Modification devices that may have packaging seals broken, risking contamination. This could lead to infections if the devices are used without proper sterility.
The packaging seal may be completely breached, which could compromise the sterility of the device. If the device is not sterile, it might cause infections during medical procedures.
Healthcare professionals using the Torq-Flex Wire Guide Australian Modification devices for medical procedures are most at risk if the packaging seal is compromised. Patients receiving procedures with these devices could face infection risks.
Check for the part number STF-18-40-AUST and lot numbers 14788615, 14816230, or 14836977. Devices sold between June 2023 and July 2027 are affected.
Look for the part number STF-18-40-AUST and lot numbers 14788615, 14816230, or 14836977 on the device packaging.
The affected part number is STF-18-40-AUST with lot numbers 14788615, 14816230, and 14836977.
Devices were sold between June 2023 and July 2027.
Compromised sterility could lead to infections if the devices are used without proper sterility.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1843-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1843-2022 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.
