Recall Z-3257-2024— Cook Biotech, Inc.

Name: FDA recall Z-3257-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-07

Class II · Ongoing

Class II FDA medical device recall by Cook Biotech, Inc., initiated 2024-08-07. It names one FDA 510(k) clearance: K062729. Product: 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: Products expire prior to the expiration date printed on the product labeling.

Recalling firm: Cook Biotech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-07
Firm location: W Lafayette, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K062729 — SURGISIS RVP RECTO-VAGINAL FISTULA PLUGCook Biotech, Inc.·cleared 2006-10-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.