Device product
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Z-2513-2024
Product summary
- Event
- Event 94976
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 51 units
- Official record key
device-enforcement:Z-2513-2024
Official wording
Reason: Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Code information: Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;
Distribution pattern: US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
Derived failure modes
-
Unknown
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.