Cook Inc. recalls Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Ga

Recalled March 6, 2019 · FDA recall Z-0967-2019 · Cook

Hazard

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

Units

797

Sold at

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.

Description

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

Product

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 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.

Manufacturer(s)

Cook Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →