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Recall Observatory FDA recall evidence

Device 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

Z-1529-2024

March 01, 2024

Class II

Product summary

Firm
Cook Incorporated
Event
Event 94196
Status
Ongoing
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-1529-2024

Official wording

Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility