Cook recalls Entuit Secure Gastrointestinal Suture Anchor Sets with specific lot numbers due to potential difficulty sliding down the retention mechanism. Affected units may require replacement to prevent complications during medical procedures.
There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
Cook is recalling certain Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause the device to slide down the retention mechanism. This could lead to complications during medical procedures if the device is not properly secured.
The device may slide down the retention mechanism due to a specific extension spring lot. This could cause the device to become loose during medical procedures, potentially leading to complications.
Medical professionals using the Entuit Secure Gastrointestinal Suture Anchor Set for stomach procedures are most at risk. Patients undergoing surgery with this device may be affected if the set is recalled.
Check the lot numbers listed: 8056941, 8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427, 8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134. The product is sold under Catalog Number GIAS-SRM-3 and Order Number G35570.
Identify the lot numbers on your device to see if they match the listed numbers: 8056941, 8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427, 8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134.
The device may slide down the retention mechanism due to a specific extension spring lot, which could lead to complications during medical procedures.
Check the lot numbers on your device. Affected units have lot numbers: 8056941, 8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427, 8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134.
No, the recall is for specific lot numbers. If your device has an affected lot number, you should check with Cook for further instructions.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0968-2019 — Cook Cook Hello, I own a Cook that is covered by recall Z-0968-2019 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.
