Home / Recalls / Cook Biotech, Inc. / Z-3256-2024

Z-3256-2024 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
39 units

Product Description

Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372

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: (01)00827002463721(17)250313(10)LB1524444 (01)00827002463721(17)250313(10)LB1524447 (01)00827002463721(17)250319(10)LB1524448 (01)00827002463721(17)250319(10)LB1524473 (01)00827002463721(17)250416(10)LB1525814 (01)00827002463721(17)250419(10)LB1530195 (01)00827002463721(17)250523(10)LB1534372 (01)00827002463721(17)250702(10)LB1539163 Lot Number: LB1524444 LB1524447 LB1524448 LB1524473 LB1525814 LB1530195 LB1534372 LB1539163

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-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-3251-2024 Class II — Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for (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)