Cook Biotech, Inc.: Medical Device Recall in 2024 - (Recall #: Z-3252-2024)

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-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612

Product Classification:

Class II

Date Initiated: August 7, 2024

Date Posted: October 2, 2024

Recall Number: Z-3252-2024

Event ID: 95149

Reason for Recall:

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

Status: Ongoing

Product Quantity: 35 units

Code Information:

UDI: (01)00827002546127(17) Lot Number: LB1524461 LB1524469 LB1524472 LB1524486 LB1529402 LB1531398 LB1537840 LB1537858

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