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
Reported: April 24, 2024 Initiated: March 1, 2024 #Z-1529-2024
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
Details
- Recalling Firm
- Cook Incorporated
- Units Affected
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cook Incorporated. Units affected: 8 units.
Why was this product recalled? ▼
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2024. Severity: Moderate. Recall number: Z-1529-2024.
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