FDA recall Z-2513-2024

W.L. Gore & Associates, Inc. · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.

Key facts

Status
Ongoing
Initiation date
2024-07-03
Report date
2024-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Elkton, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2513-2024