Events

Retiro De Equipo (Recall) de Device Recall Asahi AMBIO Series Hollow Fiber Dialyzers

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 Asahi Medical Co Ltd.

¿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
    31536
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0788-05
  • Fecha de inicio del evento
    2005-03-31
  • Fecha de publicación del evento
    2005-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-07-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38101
  • 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
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • Causa
    Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
  • Acción
    Asahi sent Henry Schein, Inc. a recall letter dated 3/30/05, requesting the recall of the affected lots of Asahi labeled product, and Henry Schein, Inc. recalled the Asahi labeled dialyzers by letter dated 3/31/05, with a copy of the Asahi 3/30/05 letter. The accounts were informed that the dialyzers may have been exposed to temperature variances during distribution, and werw requested to cease distribution/use of the specific lots listed and return them to Henry Schein for credit. The recall was expanded to include the Terumo labeled dialyzers distributed by Asahi by Henry Schein letter dated 4/13/05, accompanied by a Terumo letter dated 4/8/05, sent to the accounts via first class mail on 4/14/05. The instructions were the same as in the 3/31/05 letter. A revised letter dated 4/21/05 was sent on 4/25/05, correcting the Henry Schein product codes involved in the Terumo labeled product. Any questions were directed Asahi Kasei Medical Co. at 847-498-8500.

Device

Device Recall Asahi AMBIO Series Hollow Fiber Dialyzers
  • Modelo / Serial
    Schein product code 629-6426, Model AM-BIO-65, lot numbers 04191H, 044A4T, 0419H4A4T;  Schein product code 629-3146, Model AM-BIO-75, lot numbers 044L54, 046Q73, 044L546Q73; Schein product code 629-0041, Model AM-BIO-100, lot numbers 044J53, 04616X, 04616X626Y, 04626Y, 04626Y636B, 04636B, 04636B696K, 04696K, 046F6Q, 046F6Q6L6S, 046H6S, 046L6S, 046L6S6M6V, 046M6V, 046M6V6P72, 046P72, 046Q73
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Puerto Rico
  • Descripción del producto
    Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models AM-BIO-65 - 1.3 m2 surface area , AM-BIO-75 - 1.5 m2 surface area and AM-BIO-100 - 2.0 m2 surface area
  • Manufacturer
    Asahi Medical Co Ltd

Manufacturer

Asahi Medical Co Ltd
  • Dirección del fabricante
    Asahi Medical Co Ltd, 1-1 Uchiauwaicho,1-Chome, 14 Flr, Imperial Tower Bldg, Chiyoda Ku Japan
  • Source
    USFDA