Cook recalls Heavy Double Flexible Tipped Wire Guide devices with potential packaging seal breaches that could compromise sterility. Affected lots have specific part numbers and expiration dates. Consumers should check their device details and contact Cook for guidance.
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 Heavy Double Flexible Tipped Wire Guide devices that may have a broken packaging seal, risking loss of sterility. This could lead to infections during medical procedures if the device is used without proper sterility.
The packaging seal breach could allow contaminants to enter the sterile device packaging. If the device is used without proper sterility, it might cause infections during medical procedures.
Medical professionals using these devices for procedures are most at risk if the packaging seal is compromised. Patients receiving procedures with affected devices could face infection risks.
Check for part numbers THDOC-35-60-0-3 G11949, C-HDOC-18-40-0-2, or C-THDOC-18-40-0-2-HTS. Devices with expiration dates June 2027 or later are affected.
Identify your device using the part numbers or expiration dates listed in the recall notice.
Cook identified that some devices may have a complete breach of the chevron seal, which could compromise sterility.
Check for part numbers THDOC-35-60-0-3 G11949, C-HDOC-18-40-0-2, or C-THDOC-18-40-0-2-HTS with expiration dates June 2027 or later.
The recall notice does not specify a remedy, so contact Cook directly for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1835-2022 — Cook Cook Hello, I own a Cook that is covered by recall Z-1835-2022 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.
