Cook recalls Entuit Secure Adjustable Gastrointestinal Suture Anchor Sets due to potential packaging failure that could compromise sterility. Affected units have specific lot numbers and reference part numbers.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Cook is recalling its Entuit Secure Adjustable Gastrointestinal Suture Anchor Set because the packaging might not seal properly, risking contamination of the sterile device. This could lead to infections during medical procedures if the device is used without proper sterility.
The packaging may have weak seals that don't meet strength requirements. This could allow contamination of the sterile device, increasing infection risk during surgical procedures.
Medical professionals using the device for stomach procedures are most at risk. Patients receiving the device during surgery may be affected if the packaging fails.
Check for reference part number GIAS-SRM-ADJ-2, order number G35562, or UDI-DI (01)00827002355620(17). The lot number 15791906 is also associated with this recall.
Review the reference part number, order number, or UDI-DI to confirm if your device is affected.
The recall indicates potential packaging failure that could compromise sterility, so it is not recommended for use until the remedy is applied.
Check for reference part number GIAS-SRM-ADJ-2, order number G35562, or UDI-DI (01)00827002355620(17). The lot number 15791906 is also associated with this recall.
The recall does not specify a remedy, so contact Cook Incorporated for guidance on next steps.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1529-2024 — Cook Cook Hello, I own a Cook that is covered by recall Z-1529-2024 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.
