Z-2513-2024 Class II Ongoing
FDA device recall Z-2513-2024 was initiated by W.L. Gore & Associates, Inc. on July 3, 2024 and is designated Class II. Reason for recall: Devices were labeled with an expiration date of four years and ten days rather than the validated two years. The recall status is ongoing. Affected quantity: 51 units.
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;