W Lafayette, IN, United States
Cook Biotech, Inc. recalls
2 recalls recorded since 2018, most recently on 22 November 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 November 2024
- Reason
- Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
- Distribution
- US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0833-2025, Z-0832-2025, Z-0834-2025
- Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
- Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
- Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Ongoing Class II Medical devices
- Recall started
- 7 August 2024
- Reason
- Products expire prior to the expiration date printed on the product labeling
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3261-2024, Z-3251-2024, Z-3258-2024, Z-3257-2024, Z-3260-2024, Z-3252-2024, Z-3256-2024, Z-3250-2024, Z-3255-2024, Z-3259-2024, Z-3254-2024, Z-3253-2024
- Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
- Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
- Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
- 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
- Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
- 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
- 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
- Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
- and 4 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.