FDA Enforcement
Class II
Ongoing
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Recall: Z-2513-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2513-2024
- Event ID
- 94976
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- W.L. Gore & Associates, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- August 14, 2024
- Initiation Date
- July 3, 2024
- Classification Date
- August 6, 2024
- Address
- 301 Airport Rd, Elkton, MD, 21921-4130, United States
Description
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Reason
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Code Info
Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;
Distribution
US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
Quantity
51 units