Events

Retiro De Equipo (Recall) de Device Recall Two Lumen 14F Hemodialysis Catheter Kits/Sets

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 Arrow International 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
    28395
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0639-04
  • Fecha de inicio del evento
    2004-02-18
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-08-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31756
  • 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
    Catheter, Hemodialysis, Non-Implanted - Product Code MPB
  • Causa
    Catheter slips out of the suture wing during use.
  • Acción
    The recalling firm issued a recall letter dated 2/18/04 to their direct accounts informing them of the problem and the need to return the product.

Device

Device Recall Two Lumen 14F Hemodialysis Catheter Kits/Sets
  • Modelo / Serial
    Product number AK-22142-CF Lot numbers RF2035008, RF2067620, RF2100365, RF3023691, RF3045916, RF3078012, RF3089042, RF3099786, RF3121691, and RF3122085. Product number AK-22142-CFSP Lot numbers RF2046619, RF2046669, RF3099895, and RF3111053. Product number AK-22142-F Lot numbers RF1105891, RF2100885, RF3088793, RF3089028, RF3089202, RF3099359, RF3100354, RF4012646. Product number AK-25142-CF Lot number RF1080802, RF1094019, RF2010218, RF2067624, RF2100633, RF2100886, RF3067453, RF3088794, RF3099633, RF3100446, and RF3121805. Product number AK-25142-CFSP Lot numbers RF2010219, RF2046670, RF3100573, and RF3111264. Product number AK-25142-F Lot numbers RF1104566, RF3024351, RF3034977, RF3056501, RF3088861, RF3089029, RF3099313, and RF3100355. Product number CS-22142-CF Lot numbers RF1028262, RF1033063, RF1105890, RF2099516, RF2111093, RF3013358, RF3077978, RF3088513, RF3099272, and RF3100452. Product number CS-22142-F Lot numbers RF1033064, RF2100484, RF3045575, RF3088456, and RF3051547. Product number CS-25142-CF Lot numbers RF1082563, RF1104918, RF1105889, RF2089343, RF2100890, RF2111125, RF3056376, RF3067264, and RF3099410. Product number CS-25142-F Lot numbers RF1104919, RF2111094, RF2111192, RF2111673, RF3023765, RF3035176, RF3045410, RF3056617, RF3099369, RF3121572, and RF4012292.Product number CS-26142-F Lot numbers RF2111134, RF2111290, RF3078240, RF3088795, RF3099586, RF3100056, RF3100272, RF3111001, RF3111434, and RF3121623.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was shipped to hospitals, medical supply companies, and sales representatives nationwide. Products were also shipped to England, Belgium, Germany, Greece, Sweden, Ukraine, France, Taiwan, Australia, Netherlands, and Denmark.
  • Descripción del producto
    Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Dirección del fabricante
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA