Gastrointestinal Suture Anchor Recalled Due to Packaging Seal Defect
Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set due to packaging that may have insufficient seal strength, potentially compromising device sterility. The recalled lot is distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device with potential for sterility compromise, a significant risk for surgical implants. No illnesses or injuries have been reported, making this a risk-of-harm scenario with theoretical hazard.
Plain-English summary
Cook Incorporated is recalling the Entuit Secure Adjustable Gastrointestinal Suture Anchor Set (Reference Part Number GIAS-SRM-ADJ-2) from lot 15791906. The affected packaging may have low seal strength and does not meet peel strength specifications, which could compromise the sterility of the device.
This surgical anchor is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. The recalled lot has been distributed worldwide, including throughout the United States, Canada, and multiple other countries.
Healthcare facilities that have received this device should verify whether they have units from the affected lot 15791906 and contact Cook Incorporated for further instructions.
The recalled product
- 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
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Surgical Anchor
- Hazard
- sterility-compromise
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)00827002355620(17) Lot Number: 15791906
Distribution
Distributed nationwide across the United States.
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