Events

Retiro De Equipo (Recall) de Device Recall CADD BlueStriped Administration Set

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 Smiths Medical ASD 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
    77791
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2759-2017
  • Fecha de inicio del evento
    2016-12-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157885
  • 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
    IV administration set - Product Code FPA
  • Causa
    The label of the cadd blue-striped administrative set is missing the expiration date, which is considered a regulatory compliance issue for canada.
  • Acción
    Customers were sent an Urgent Medical Device Safety Notice, dated 12/9/2016. The letter identified affected product and stated the reason for recall. The letter also provided a list of devices that each consignee ordered, along with the date of manufacture and associated expiration date. Customers were asked to locate devices and compare to the list and determine if affected devices are within expiration date. If the device is expired customers are to dispose of them per their procedures for dealing with expired product. If devices are not expired, they may continue to use them through the expiration date. A response form was asked to be returned within 10 day s of receipt of the letter. Questions can be directed to smithsmedical6185@stericycle.com

Device

Device Recall CADD BlueStriped Administration Set
  • Modelo / Serial
    Lot No.: 010X47, 025X47, 064X46, 079X48, 094X46, 103X46, 108X49, 155X40, 170X47, 173X47, 187X49, 193X45, 208X40, 208X45, 217X46, 224X46, 230X44, 241X40, 268X40, 286X40, 41X065, 41X099, 41X173, 41X221, 41X284, 41X302, 41X366, 41X399, 41X506, 42X047, 42X154, 42X238, 42X266, 42X302, 42X393, 42X505, 431X40, 43X013, 43X099, 43X125, 43X166, 42X259, 43X298, 43X357, 43X424, 43X467, 43X527, 43X549, 44X053, 44X110, 44X169, 44X197, 44X272, 44X359, 44X388, 44X442, 44X493, 44X547, 44X567, 44X596, 44X682, 44X704, 44X714, 45X074, 45X091, 45X142, 45X234, 45X246, 45X260, 45X346, 45X424, 45X538, 46X023, 46X141, 46X181, 46X228, 46X255, 46X429, 46X430, 46X475, 46X490, 46X543, 46X631
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Canada only
  • Descripción del producto
    Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Dirección del fabricante
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    USFDA