Home / Recalls / Cook Biotech, Inc. / Z-3257-2024

Z-3257-2024 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
130 units

Product Description

Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373

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)00827002463738(17)250319(10)LB1524437 (01)00827002463738(17)250319(10)LB1524441 (01)00827002463738(17)250319(10)LB1524453 (01)00827002463738(17)250402(10)LB1524456 (01)00827002463738(17)250319(10)LB1524457 (01)00827002463738(17)250402(10)LB1524484 (01)00827002463738(17)250408(10)LB1524495 (01)00827002463738(17)250402(10)LB1525243 (01)00827002463738(17)250416(10)LB1525244 (01)00827002463738(17)250402(10)LB1525249 (01)00827002463738(17)250416(10)LB1528983 (01)00827002463738(17)250416(10)LB1528999 (01)00827002463738(17)250416(10)LB1529377 (01)00827002463738(17)250626(10)LB1529380 (01)00827002463738(17)250429(10)LB1529383 (01)00827002463738(17)250419(10)LB1529680 (01)00827002463738(17)250429(10)LB1530192 (01)00827002463738(17)250429(10)LB1530299 (01)00827002463738(17)250429(10)LB1530308 (01)00827002463738(17)250520(10)LB1530309 (01)00827002463738(17)250523(10)LB1530310 (01)00827002463738(17)250531(10)LB1531363 (01)00827002463738(17)250531(10)LB1531404 (01)00827002463738(17)250531(10)LB1531406 (01)00827002463738(17)250603(10)LB1534887 (01)00827002463738(17)250626(10)LB1534888 Lot Number: LB1524437 LB1524441 LB1524453 LB1524456 LB1524457 LB1524484 LB1524495 LB1525243 LB1525244 LB1525249 LB1528983 LB1528999 LB1529377 LB1529380 LB1529383 LB1529680 LB1530192 LB1530299 LB1530308 LB1530309 LB1530310 LB1531363 LB1531404 LB1531406 LB1534887 LB1534888

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-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-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)