FDA Enforcement
Class II
Ongoing
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
Recall: Z-1529-2024
·
Reported April 24, 2024
Enforcement
- Recall Number
- Z-1529-2024
- Event ID
- 94196
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2024
- Initiation Date
- March 1, 2024
- Classification Date
- April 12, 2024
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120, United States
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
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Code Info
UDI-DI: (01)00827002355620(17) Lot Number: 15791906
Distribution
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Quantity
8 units