Home / Recalls / Medical Devices
Cook Incorporated recalls Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to
Recalled April 24, 2024 · FDA recall Z-1529-2024 · Cook Incorporated
Hazard
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility · FDA Class II
Units
8 units
Sold at
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Description
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Product
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
Manufacturer(s)
Cook Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →