Events

Retiro De Equipo (Recall) de SODASORB LF PrePaks

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 Darex Container Products Div of W.R. Grace & Co..

¿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
    57064
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0561-2011
  • Fecha de inicio del evento
    2010-10-20
  • Fecha de publicación del evento
    2010-12-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95503
  • 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
    Absorbent, cargon dioxide - Product Code CBL
  • Causa
    Pre-pak units of sodasorb co2 absorbent manufactured prior to august 2010 may have missing or illegible expiration dates and/or batch numbers.
  • Acción
    Darex/W.R. Grace sent a Customer Notification to their sole direct account of the recall and the account provided Darex/W.R. Grace with lists of their customers who received the recalled products. Darex then sent undated recall letters to those accounts on 10/20-22/10. The accounts were informed of the product, the problem, and the action that should be taken. The accounts were warned not to use Pre-Pak units with missing or illegible expiration dates and/or batch numbers and were requested to examine their inventories of Pre-Pak units, placing all units that had missing or illegible expiration dates and/or batch numbers on hold for destruction and replacement. The accounts were instructed to call W.R. Grace at 1-800-492-7632 to arrange for replacement. The accounts were also requested to complete and return the reply postcard, indicating how much product was destroyed.

Device

SODASORB LF PrePaks
  • Modelo / Serial
    Batch Numbers: CX01-P128-04, CX01-P128-08, CX02-P128-04, CX02-P128-05, CX02-P128-08, CX06-P128-02, CX07-P128-01, CX07-P128-02, CX12-P128-03, CX12-P128-04, CX12-P128-05, CX12-P128-07, CZ03-P128-09, CZ07-P128-01, CZ07-P128-01, CZ07-P128-10 and CZ07-P128-11.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Grace SODASORB LF Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorbent is depleted or upon moisture loss; Manufactured by: W.R. Grace & Co., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks pre-filled 2.5 lb. canisters, 12 per carton || Sodasorb LF is used for absorption of carbon dioxide in low flow anesthesia rebreathing systems and respiratory therapy equipment with oxygen, nitrous oxide, halothane, enflurane, desflurane, sevoflurane and isoflurane.
  • Manufacturer
    Darex Container Products Div of W.R. Grace & Co.

Manufacturer

Darex Container Products Div of W.R. Grace & Co.
  • Dirección del fabricante
    Darex Container Products Div of W.R. Grace & Co., 6050 W 51st St, Chicago IL 60638-1405
  • Source
    USFDA