Events

Recall of Asahi KASEI, REXEED(TM) 15 SX, HEMODIALYZER

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

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
    63146
  • Event Risk Class
    Class 2
  • Event Number
    Z-2418-2012
  • Event Initiated Date
    2012-09-21
  • Event Date Posted
    2012-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112680
  • 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
    Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
  • Action
    AsahiKASEI Medical Co., LTD sent a Medical DeviceRecall letter on September 21, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm that they have no inventory and to forward the letter to all clinics who may have received the product requesting they check their stock and arrange for the return of any recalled product. Non-responding consignees will be contacted by telephone. For questions regarding this recall call Asaki Kasei Medical America, Inc. at 888-362-6105.

Device

Asahi KASEI, REXEED(TM) 15 SX, HEMODIALYZER
  • Model / Serial
    Lot numbers: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
  • Product Description
    Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER || dialysis filter
  • Manufacturer
    Asahi Kasei Medical Co., Ltd., Okatomi Plant

Manufacturer

Asahi Kasei Medical Co., Ltd., Okatomi Plant
  • Manufacturer Address
    Asahi Kasei Medical Co., Ltd., Okatomi Plant, 4960 5 Chome Nakagawara Cho, Nobeoka-shi Japan
  • Manufacturer Parent Company (2017)
    Asahi Kasei Corp.
  • Source
    USFDA