GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Reported: August 14, 2024 Initiated: July 3, 2024 #Z-2513-2024
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.
Details
- Recalling Firm
- W.L. Gore & Associates, Inc.
- Units Affected
- 51 units
- Distribution
- US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
- Location
- Elkton, MD
Frequently Asked Questions
What product was recalled? ▼
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;. Recalled by W.L. Gore & Associates, Inc.. Units affected: 51 units.
Why was this product recalled? ▼
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2024. Severity: Moderate. Recall number: Z-2513-2024.
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