Events

Recall of Device Recall Asahi APS Series Dialyzers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Asahi Medical Co Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    28341
  • Event Risk Class
    Class 2
  • Event Number
    Z-0739-04
  • Event Initiated Date
    2001-10-01
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31622
  • Notes / Alerts
    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.
  • Extra notes in the data
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • Reason
    Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
  • Action
    Asahi visited each of the U.S. customers starting on 10/1/01, observing how the facility handles the dialyzer before pre-cleaning, during pre-cleaning and priming. The users were retrained in the reprocessing steps, emphasizing the controls and care to be taken during pre-cleaning, including the verification of water pressure.

Device

Device Recall Asahi APS Series Dialyzers
  • Model / Serial
    Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S. The recall is no lot specific.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    New Jersey, Ohio, Texas, California, Georgia, Pennsylvania, Illinois and Indiana
  • Product Description
    Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo rup to 15 reuse cycles; Manufacturer: Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Distributed in teh USA by Nextron Medical, 45 Kulick Road, Fairfield, NJ 07004 USA
  • Manufacturer
    Asahi Medical Co Ltd

Manufacturer

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