Events

Recall of Asahi AMBIO Series Hollow Fiber 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
    36430
  • Event Risk Class
    Class 3
  • Event Number
    Z-0173-2007
  • Event Initiated Date
    2006-10-12
  • Event Date Posted
    2006-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48644
  • 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
    Hollow Fiber Dialyzers - Product Code MSE
  • Reason
    There have been reports of difficulty separating the gambro cartridge blood set from asahi reuse/multiple use dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.
  • Action
    Asahi sent Safety Alert letters on 10/12/06 to their re-use dialyzer customers advising them of the reports of difficulty separating the blood set from the dialyzer and not to use the Gambro Cartridge Blood Set with Asahi Reuse/Multiple Use Dialyzers in a reuse situation. Enclosed were copies of the temporary revision Instructions For Use with the following warning added at the top of the page: 'Additional Warning for Reuse/Multiple Use Dialyzers: Ashai Reuse/Multiple use dialyzers must not be used in connection with the Gambro cartridge Blood Set in a reuse environment.' Any questions were directed to Karen Borling, RN at 847-498-8500.

Device

Asahi AMBIO Series Hollow Fiber Dialyzers
  • Model / Serial
    Model AM-BIO-65, Model AM-BIO-75 and Model AM-BIO-100, all lots
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or 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; Model AM-BIO-65 - 1.3 m2 surface area, Model AM-BIO-75 - 1.5 m2 surface area and Model AM-BIO-100 - 2.0 m2 surface area
  • Manufacturer
    Asahi Medical Co., Ltd

Manufacturer

Asahi Medical Co., Ltd
  • Manufacturer Address
    Asahi Medical Co., Ltd, 3100 Dundee Rd Ste 201/202, Northbrook IL 60062-2437
  • Source
    USFDA