FDA-Device2024-04-24Class II
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
Hazard
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Sold states
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Affected count
8 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2024More Cook Incorporated recalls
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- FDA-Device2026-04-15Cook Medical Strange Bile Duct Stone Exploration Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Wayne Pneumothorax Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Blue Rhino G2 tracheostomy introducer tray recalled for incorrect expiration dates
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