Events

Retiro De Equipo (Recall) de Device Recall Baxter Minicap Extended Life PD Transfer Set Extra SHort (4") with Twist Clamp

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 Baxter Healthcare Corp..

¿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
    52560
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1894-2009
  • Fecha de inicio del evento
    2009-07-02
  • Fecha de publicación del evento
    2009-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83935
  • 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
    Set, administration, for peritoneal dialysis, disposable - Product Code KDJ
  • Causa
    The peritoneal dialysis transfer set has a defective white sleeve twist clamp. the twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.
  • Acción
    Baxter Healthcare Corporation telephoned the accounts receiving the affected lots and then faxed or e-mailed "Urgent Product Recall" letters dated July 2, 2009, to them, to the attention of the Peritoneal Dialysis Nurse, to inform them of the defective white sleeve twist clamp, which may result in leakage and possible peritonitis. The accounts were asked to immediately discontinue the use of the affected lot numbers and examine their inventory for the affected lots. If any affected product was found, they were requested to quarantine it and contact Baxter Center for Service at 1-888-229-0001 to arrange for its return to Baxter. The accounts were also requested to review their patient records to determine if any of their patients had received the affected product. If so, they were advised to contact the patients to see if they had experienced any leaking. If so, the patients should return to the facility to have the set changed per the facility's transfer set change procedure. Any questions were directed to the Center for One Baxter at 1-800-422-9837, Monday through Friday, 8:00 a.m. to 5:00 p.m. Central Standard Time (CST). The accounts were requested to complete the enclosed reply form acknowledging receipt of the letter and that they followed the instructions and disseminated the information to their staff.

Device

Device Recall Baxter Minicap Extended Life PD Transfer Set Extra SHort (4") with Twist Clamp
  • Modelo / Serial
    Product code 5C4483, lot number H09E18044.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador.
  • Descripción del producto
    Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4483 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA