FDA-Device2024-08-14Class II
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
W.L. Gore & Associates, Inc.
Hazard
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Sold states
US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.
Affected count
51 units
Manufactured in
301 Airport Rd, Elkton, MD, United States
Products
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2513-2024Don't want to check this manually?
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