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Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior...

FDA Recall #Z-1529-2024 — Class II — March 1, 2024

Recall #Z-1529-2024 Date: March 1, 2024 Classification: Class II Status: Ongoing

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

Recalling Firm

Cook Incorporated — Bloomington, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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.

Code Information

UDI-DI: (01)00827002355620(17) Lot Number: 15791906

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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