Z-2513-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- July 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51 units
Product Description
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Reason for Recall
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Distribution Pattern
US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
Code Information
Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;