Recall Z-2513-2024 ยท FTL Mesh, Surgical, Polymeric
W.L. Gore & Associates, Inc.
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
| Date | Aug 6, 2024 (initiated Jul 3, 2024) |
| Status | Open, Classified |
| Reason | Devices were labeled with an expiration date of four years and ten days rather than the validated two years. |
| Root cause | Process control |
| Action | On July 1, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the customer/user: 1. Identify and return any unused devices within the scope of this recall for replacement. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to FieldActionTeam@wlgore.com within 2 weeks of receipt of this notification. 3. This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred (as appropriate). 4. If a listed device has been used, there is no p |
| Quantity | 51 units |
| Distribution | US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053200 | GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc., Dec 7, 2005 |