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FDAMarch 1, 2024device

Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

What to do

FDA enforcement status: Ongoing

Brands named

cook

UPCs

00827002355620

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562 — Recall Details · AllClear