Recall Z-1529-2024 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook Incorporated
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
| Date | Apr 12, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| Reason | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| Root cause | Under Investigation by firm |
| Action | Cook Medical issued Urgent Medical Device Recall letter on 3/1/24 to Risk Management/Recall Administration. . Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form |
| Quantity | 8 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set Cook Incorporated, Sep 30, 2015 |