Recall Z-2513-2024— W.L. Gore & Associates, Inc.
Class II · Ongoing
Class II FDA medical device recall by W.L. Gore & Associates, Inc., initiated 2024-07-03. It names one FDA 510(k) clearance: K053200. Product: 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..
- Recalling firm
- W.L. Gore & Associates, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-03
- Firm location
- Elkton, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.