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FDADecember 19, 2018device

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

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

The hazard

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

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

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