Device 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
Z-1529-2024
Product summary
- Event
- Event 94196
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-1529-2024
Official wording
Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Code information: UDI-DI: (01)00827002355620(17) Lot Number: 15791906
Distribution pattern: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Derived failure modes
-
Unknown
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility