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Recall Observatory FDA recall evidence

Device product

Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374

Z-3255-2024

August 07, 2024

Class II

Product summary

Firm
Cook Biotech, Inc.
Event
Event 95149
Status
Ongoing
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-3255-2024

Official wording

Reason: Products expire prior to the expiration date printed on the product labeling

Code information: UDI: (01)00827002463745(17)250319(10)LB1524446 Lot Number: LB1524446

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Canada, China, Finland, France, Germany, Ireland, Luxembourg, Netherlands, New Zealand, Norway, South Africa, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Products expire prior to the expiration date printed on the product labeling