FDAFDA · Food and drugs·Recall number Z-2513-2024
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Published August 14, 2024 · Recall initiated: July 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- W.L. Gore & Associates, Inc.
- Distributor
- US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
- Lot
- Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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