Events

Retiro De Equipo (Recall) de Device Recall Outlook Pump IV Set w/Universal Spike Check Valve, 4 Ultrasite Inj Sites, 3 B/C Valves, Spin Lock Co

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 B. Braun Medical, Inc..

¿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
    Recall
  • ID del evento
    53955
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0691-2010
  • Fecha de inicio del evento
    2009-11-24
  • Fecha de publicación del evento
    2010-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87304
  • 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
    Intravascular administration set - Product Code FPA
  • Causa
    System error 9 alarms. a system error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). this alarm is generated during the pumps initiation sequence and will not allow the set to be used. this requires a new set to be obtained, thus creating a potential for delay in therapy.
  • Acción
    The recalling firm issued a Product Removal Notice via US Postal Service Certified Mail with registered return receipt or FedEx to all customers and distributors in receipt of the affected product. The notices were sent 11/30/09 and 12/1/09. Direct customers also received letters addressed to Material Management that informed them of the recall and provided instruction for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers. Questions are directed to the company's Customer Support Departments: US customers please call (800) 227-2862. Canadian customers, please call (800) 624-2920. International customers, please call (610) 691-5400.

Device

Device Recall Outlook Pump IV Set w/Universal Spike Check Valve, 4 Ultrasite Inj Sites, 3 B/C Va...
  • Modelo / Serial
    Product Code 470042. Lot numbers: 61057030 exp 4/30/2012, 61057031 exp 4/30/2012, 61057693 exp 5/31/2012, 61060762 exp 5/31/2012, and 61060767 exp 6/30/2012.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The products were shipped to distributors and medical facilities nationwide. The product was also shipped to Afghanistan, Canada and LU.
  • Descripción del producto
    Outlook Pump IV Set w/Universal Spike Check Valve, 4 Ultrasite Inj Sites, 3 B/C Valves, Spin Lock Connector 140 in US1504HP
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Dirección del fabricante
    B. Braun Medical, Inc., 901 Marcon Boulevard, Allentown PA 18109-9512
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA