Z-1529-2024 Class II Ongoing
FDA device recall Z-1529-2024 was initiated by Cook Incorporated on Mar 1, 2024 and is designated Class II. Reason for recall: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility The recall status is ongoing. Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 24, 2024
- Initiation Date
- Mar 1, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
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
Reason for Recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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.
Code Information
UDI-DI: (01)00827002355620(17) Lot Number: 15791906
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1529-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026