FDAFDA · Alimentos y medicamentos·N.º oficial Z-3257-2024
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
Publicado el 2 de octubre de 2024 · Inicio del retiro: 7 de agosto de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Products expire prior to the expiration date printed on the product labeling
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Cook Biotech, Inc.
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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