Home / Recalls / Cook Biotech, Inc. / Z-3251-2024

Z-3251-2024 Class II Ongoing

Recalled by Cook Biotech, Inc. — W Lafayette, IN

Recall Details

Product Type
Devices
Report Date
October 2, 2024
Initiation Date
August 7, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

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

Reason for Recall

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

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.

Code Information

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

Other recalls by Cook Biotech, Inc.

  • Z-0833-2025 Class II — Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Steril (November 22, 2024)
  • Z-0834-2025 Class II — Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile (November 22, 2024)
  • Z-0832-2025 Class II — Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G (November 22, 2024)
  • Z-3257-2024 Class II — Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue f (August 7, 2024)
  • Z-3258-2024 Class II — Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce sof (August 7, 2024)
  • Z-3256-2024 Class II — Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue f (August 7, 2024)
  • Z-3255-2024 Class II — Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue f (August 7, 2024)
  • Z-3260-2024 Class II — Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce sof (August 7, 2024)
  • Z-3250-2024 Class II — Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for (August 7, 2024)
  • Z-3253-2024 Class II — Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for (August 7, 2024)