Entuit Secure Adjustable Gastrointestinal Suture Anchor recall: Sterility Concern
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to…
Why was Entuit Secure Adjustable Gastrointestinal Suture Anchor recalled?
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)00827002355620(17) Lot Number: 15791906
- Product
- Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to…
- Recalling firm
- Cook Incorporated
- 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.
- Recall date
- April 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)