Events

Recall of Device Recall Asahi APS 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
    31536
  • Event Risk Class
    Class 2
  • Event Number
    Z-0790-05
  • Event Initiated Date
    2005-03-31
  • Event Date Posted
    2005-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38104
  • 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
    Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.
  • Action
    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 APS Series Hollow Fiber Dialyzers
  • Model / Serial
    Schein product code 629-4923, Model APS-21R, lot numbers U4383Y, U4383Y8K8N, X46R6V, W4797A, W4797A7X7B, X47X7B, X47X7B7Q7U, W47Q7U, W47Q7U7R7U, W47R7U, W48K8N
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Puerto Rico
  • Product Description
    Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone 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 APS-21R - 2.1 m2 surface area
  • 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