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
Recall
- Recall Number
- Z-1529-2024
- Event Number
- 94196
- Firm
- Cook Incorporated
- FEI Number
- 1820334
- Product Code
- FGE
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 1, 2024
- Posted
- April 12, 2024
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120
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
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Cook Medical issued Urgent Medical Device Recall letter on 3/1/24 to Risk Management/Recall Administration. . Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. Action being Taken by Cook Medical Cook Medical is removing potentially affected products from the market. Additionally, a supplier investigation has been opened to determine the appropriate corrective action(s) to prevent reoccurrence of a similar issue.
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
8 units