Events

Retiro De Equipo (Recall) de Device Recall Sabraset Administration Sets with Auto 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
    30506
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0386-05
  • Fecha de inicio del evento
    2004-11-19
  • Fecha de publicación del evento
    2005-01-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36055
  • 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, Intravascular - Product Code FPA
  • Causa
    A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. this can lead to free-flow of the solution and a possible overdose of medication to the patient.
  • Acción
    Urgent Product Recall letters dated 11/19/04 were sent to the direct accounts on the same date via UPS ground. The accounts were informed that free-flow situations were associated with the listed product codes and lot numbers due to a missing platen assembly in the cassette of the solution sets, which could result in an overdose of medication to the patient. The accounts were requested to stop use of the affected lot numbers and product codes and return the sets to Baxter c/o NNC Group, 2670 Executive Dr., Indianapolis, IN 46241, following the enclosed instructions. Any questions concerning the return process were directed to NCC at 1-866-300-5085. Any medical or technical questions were directed to Baxter at 1-800-422-9837.

Device

Device Recall Sabraset Administration Sets with Auto Clamp
  • Modelo / Serial
    Product codes 560500-100 and 560500-250, all lot numbers other than lots produced within the range of 417519 to 499999, or those with an adhesive circular colored sticker (Avery dot) at the top of the individual package on the Tyvek side or on the shipper label.  Any lot numbers from the following obsolete Sabraset product codes are also being recalled: 5600PM, 560100, 560101, 560110, 560111, 560112, 560112-GEL, 560112-L, 560113, 560115, 560116, 560122-L, 561101, 567100, 567100-L, 567112-L, 567122-L, 569100, 569111, 569122, 560200-100, 560522-100
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, including Puerto Rico, and internationally to Australia, Belgium, Canada, Hong Kong, Israel, Japan, Singapore, Sweden and Switzerland
  • Descripción del producto
    Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., the following sets were made in Mexico: || a) Sabraset 56050 ¿ 100 Administration Set with 100 mL Bag and Cassette, 56'', Volume 3 mL, 100 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter || b) Sabraset 56050 ¿ 250 Administration Set with 2500 mL Bag and Cassette, 53'', Volume 3 mL, 250 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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