Cook Biotech, Inc.: Medical Device Recall in 2024 - (Recall #: Z-3256-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 7, 2024

Date Posted: October 2, 2024

Recall Number: Z-3256-2024

Event ID: 95149

Reason for Recall:

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

Status: Ongoing

Product Quantity: 39 units

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated