FDAFDA · Alimentos y medicamentos·N.º oficial Z-2542-2014
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
Publicado el 3 de septiembre de 2014 · Inicio del retiro: 3 de julio de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Becton Dickinson & Company
- Distribuidor
- US and Foreign
- Lote
- A) REF #362753, 8 mL,16 x 125 mm, Lot #'s 4063409, 4063413 and 4063414 with expiry 03/15, Lot #'s 4090214, 4090215 and 4090216 with expiry 04/15; B) REF #362760, 4 mL, 13 x 100 mm, Lot #4063412 with expiry 03/15; C) REF #362761, 8 mL, 16 x 125 mm, Lot #'s 4063410, 4063411, 4063415, 4063416, 4063417, 4063418 and 4063419 with expiry 03/15; Lot #'s 4090230, 4090232, 4090234 and 4090237 with expiry 04/15. Outside US D) REF #362780, 8 mL, 16 x 125 mm, Lot #'s 4063420 and 4063455 with expiry 03/15; Lot #'s 4090241 and 4090242 with expiry 04/15. E) REF #362781, 4 mL, 13 x 100 mm, Lot # 4063421 with expiry 03/15 F) REF #362782, 8 mL, 16 x 125 mm, Lot #'s 4063422 and 4063423 with expiry 03/15; Lot #'s 4090244 and 4090246 with expiry 04/15
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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