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.
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 they might slide down the retention mechanism, which could cause problems during medical procedures. This recall affects patients who have received these specific sets for stomach surgery.
The sets have a specific extension spring lot that can cause difficulty sliding down the retention mechanism. This could lead to improper anchoring during stomach surgery, potentially causing complications.
Patients who have received the recalled Entuit Secure Gastrointestinal Suture Anchor Sets for stomach surgery are most at risk. Healthcare providers using these sets for medical procedures may also be affected.
Check the lot numbers on the product: 8144390, 8159665, 8173295, 8204594, 8261263, 8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, 8582863X. These sets were sold with Catalog Number GIAS-SRM-2 and Order Number G35569.
Look for the specific lot numbers listed in the recall: 8144390, 8159665, 8173295, 8204594, 8261263, 8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, 8582863X.
The sets have a specific extension spring lot that can cause difficulty sliding down the retention mechanism, which might lead to improper anchoring during stomach surgery.
Check the lot numbers on the product: 8144390, 8159665, 8173295, 8204594, 8261263, 8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, 8582863X.
The recall does not require stopping use; the hazard is low risk and the remedy is not specified.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-0967-2019 — Cook Cook Hello, I own a Cook that is covered by recall Z-0967-2019 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.
