Events

Retiro De Equipo (Recall) de Device Recall Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limited Check V

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-0685-2010
  • 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=87298
  • 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 Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressur...
  • Modelo / Serial
    Product Code 375196. Lot numbers: 61044265 exp 2/28/2012, 61044267 exp 2/28/2012, 61044278 exp 2/28/2012, 61044279 exp 2/28/2012, 61044280 exp 2/28/2012, 61044281 exp 2/28/2012, 61044282 exp 2/28/2012, 61044283 exp 2/28/2012, 61044285 exp 3/31/2012, 61049092 exp 3/31/2012, 61049093 exp 3/31/2012, 61049095 exp 3/31/2012, 61049097 exp 3/31/2012, 61049108 exp 3/31/2012, 61049109 exp 3/31/2012, 61049110 exp 3/31/2012, 61049111 exp 3/31/2012, 61049113 exp 3/31/2012, 61049119 exp 3/31/2012, 61049123 exp 3/31/2012, 61049124 exp 3/31/2012, 61049125 exp 3/31/2012, 61049126 exp 4/30/2012, 61049127 exp 4/30/2012, 61049130 exp 4/30/2012, 61049131 exp 4/30/2012, 61049132 exp 4/30/2012, 61049133 exp 4/30/2012, 61049135 exp 4/30/2012, 61049137 exp 4/30/2012, 61049139 exp 4/30/2012, 61049140 exp 4/30/2012, 61049141 exp 4/30/2012, 61049143 exp 4/30/2012, 61049144 exp 4/30/2012, 61051044 exp 4/30/2012, 61051045 exp 4/30/2012, 61051046 exp 4/30/2012, 61051047 exp 5/31/2012,61051048 exp 5/31/2012, 61051049 exp 5/31/2012, 61051051 exp 5/31/2012, 61051053 exp 5/31/2012, 61051054 exp 5/31/2012, 61051055 exp 5/31/2012, 61051056 exp 5/31/2012, 61055284 exp 5/31/2012, 61055293 exp 5/31/2012, 61055294 exp 5/31/2012, 61055295 exp 5/31/2012, 61055296 exp 5/31/2012, 61057005 exp 5/31/2012, 61057006 exp 5/31/2012, 61057008 exp 6/30/2012, 61057009 exp 6/30/2012, 61057010 exp 6/30/2012, 61059668 exp 6/30/2012, 61059670 exp 6/30/2012, 61059671 exp 6/30/2012, 61059672 exp 6/30/2012, 61059673 exp 6/30/2012, 61060068 exp 6/30/2012, 61060069 exp 6/30/2012, 61060070 exp 6/30/2012, 61060071 exp 6/30/2012, 61060072 exp 6/30/2012, 61060075 exp 7/31/2012, 61060076 exp 7/31/2012, 61060077 exp 7/31/2012, 61060078 exp 7/31/2012, 61062981 exp 7/31/2012, 61062982 exp 7/31/2012, 61062983 exp 7/31/2012, 61062984 exp 7/31/2012, 61062985 exp 7/31/2012, 61062986 exp 7/31/2012, and 61062987 exp 7/31/2012.
  • 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 Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limited Check Valve, 134 in US3140
  • 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