GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement recall
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Why was GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement recalled?
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;
- Product
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
- Recalling firm
- W.L. Gore & Associates, Inc.
- Quantity
- 51 units
- Distribution
- US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
- Recall date
- August 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)