Retiro De Equipo (Recall) de Device Recall BD UltraFine(TM) and UltraFine(TM) II

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Becton Dickinson & Company.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Syringe, piston - Product Code FMF
  • Causa
    Product mislabel. lot 6291768 of the bd insulin syringes with the bd ultra-fine needle ¿ml 12.7mm 30g, cat (ref) 328466, was found to have some polybags in the lot incorrectly labeled as bd ultra-fine needle ¿ml 8mm 31g, cat (ref) 328468. the shelf carton and case carton are correctly labeled as bd ultra-fine needle ¿ml 12.7mm 30g.
  • Acción
    BD sent recall notification letters to all direct consignees (wholesaler, hospital, and retail) on May 25, 2017. BD is requesting wholesalers (distributors) to notify any accounts or additional locations that may have received the recalled product from them. BD gives the option to distributors to provide their customer list to BD if they would like BD to notify their customers. BD is requesting retail pharmacies to notify consumers that may have received the recalled product from them. 8/25/17 Firm notified FDA of recall expansion to include Lot Numbers 6312558 and 6340590. A 2nd notification was sent to consignees in a letter dated Aug 30, 2017 that includes all 3 lots that are in scope of the recall. Most of the direct consignees identified in the first recall action were also identified as affected for the second (expanded) recall action since they received either two or all three recall lots. All affected consignees that received any of the three lots have been combined into one consignee list. These customers will be notified of the expanded recall communication (second recall letter dated Aug 30, 2017). To minimize customer disruption, BD will conduct effectiveness check on the second recall letter only, since it covers the recall action for all three affected lots and combines all affected consignees from both actions (first and second/expanded recall). This will allow us to verify that the affected consignees received the notification and took the necessary actions for all three recall lots without having to contact them multiple times for two different letters that cover the same recall action. Details of the effectiveness are as follows: 1.Letters will be mailed with UPS tracking. The effectiveness check level will be established by the FDA classification letter. 2.A Business Response Card is included with the letter to assist direct consignees in responding to the field action. 3.BD will attempt to contact by phone/email (as applicable) non-respondents


  • Modelo / Serial
    Lot Numbers: 6291768, 6312558 & 6340590. 8/25/17 Firm notified FDA of recall expansion to include Lot Numbers 6312558 and 6340590.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA
  • Descripción del producto
    BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 || BD Insulin Syringes are intended for the subcutaneous injection of insulin
  • Manufacturer


  • Dirección del fabricante
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Empresa matriz del fabricante (2017)
  • Source