Cook Inc. recalls Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gast…

Recall date

December 19, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0968-2019

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) to of states: AL, AZ, CA, GA, HI, IL, IN, KY, LA, MI, MN, MO, NC, NJ, NY, OH, PA, RI, TN, TX, and UT; and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Spain, and Switzerland.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.