Events

Retiro De Equipo (Recall) de Device Recall Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector

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 SALTER LABS.

¿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
    62272
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1898-2012
  • Fecha de inicio del evento
    2012-05-30
  • Fecha de publicación del evento
    2012-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110043
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Causa
    A complaint was received, and later verified, that product labeled as so-1296 with male luer lock connector actually contained product with a female luer lock connector.
  • Acción
    The firm, Salter Labs, called their customers to discuss the recall and followed up with a "PRODUCT RECALL" letter dated May 29, 2012. The letter was distributed to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any of the lots in their possession to Salter Labs; contact Salter Labs Customer Service at 1-800-235-4203 to arrange for return of the product, and complete and return the attached form/record via fax to: 661-854-6816 or Toll Free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.

Device

Device Recall Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector
  • Modelo / Serial
    Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
  • Descripción del producto
    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. || 7 ft, oxygen tube, 7 ft. CO2 tube || RX only.For Single Patient Use only. || Distributed by Tri-Anium || Assembled in Mexico. || Usage: Delivery of Anesthesia.
  • Manufacturer
    SALTER LABS

Manufacturer

SALTER LABS
  • Dirección del fabricante
    SALTER LABS, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA