FDAFDA · Alimentos y medicamentos·N.º oficial Z-1746-2017
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
Publicado el 12 de abril de 2017 · Inicio del retiro: 16 de marzo de 2017
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 is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Becton Dickinson & Company
- Distribuidor
- Worldwide - US Nationwide Distribution
- Lote
- Catalog Number: 367716 - Lot numbers: 5251673 with expiry 3/31/2017; 6064542 with expiry 9/30/17; 6187520 with expiry 1/31/2018 and 6253669 with expiy 3/31/18 Catalog Number: 369714 - Lot numbers: 5272777 with expiry 4/30/17; 5336909 with expiry 6/30/17; 5357632 with expiry 7/31/17; 6040953 and 6064634 both with expiry 9/30/17; 6090572 with expiry 10/31/17; 6124932 with expiry 11/30/17; 6173983 with expiry 12/31/17; 6187600 with expiry 1/31/18 and 6216656 with expiry 2/28/18 Lot numbers 6064542, 6187520 and 6253669 - limited to distribution outside the U.S. market. UDI for lot 6253669 is DI (01)30382903677161, PI (17)180331(10)6253669(30)0100 and lot 6216656 is DI (01)30382903697145, PI (17)180228(10)6216656(30)0100; for all other lots UDI is not applicable based on manufacture date.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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