Device product

Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668

Z-3251-2024

August 07, 2024

Class II

Product summary

Firm: Cook Biotech, Inc.
Event: Event 95149
Status: Ongoing
Classification: Class II
Quantity: 3 units
Official record key: device-enforcement:Z-3251-2024

Official wording

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

Code information: UDI-DI: (01)00827002246683(17)250605(10)LB1536090 (01)00827002246683(17)250627(10)LB1536126 Lot Number: LB1536090, LB1536126

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