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Recall Observatory FDA recall evidence

Device product

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

Z-2513-2024

July 03, 2024

Class II

Product summary

Firm
W.L. Gore & Associates, Inc.
Event
Event 94976
Status
Ongoing
Classification
Class II
Quantity
51 units
Official record key
device-enforcement:Z-2513-2024

Official wording

Reason: Devices were labeled with an expiration date of four years and ten days rather than the validated two years.

Code information: Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Devices were labeled with an expiration date of four years and ten days rather than the validated two years.