Events

Recall of Device Recall Toray Toraysulfone Hollow Fiber Dialyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Toray Marketing & Sales (America), Inc.

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
    28027
  • Event Risk Class
    Class 2
  • Event Number
    Z-0352-04
  • Event Initiated Date
    2003-12-30
  • Event Date Posted
    2004-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31065
  • 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, Capillary, Hollow Fiber - Product Code FJI
  • Reason
    Potential loose header (end cap) on hollow fiber dialyzers.
  • Action
    Firm notified all consignees by phone call on 1/2/2004 and 1/5/2004. Firm is also notifying all consignees by letter with a response form, sent by certified mail.

Device

Device Recall Toray Toraysulfone Hollow Fiber Dialyzer
  • Model / Serial
    Lot numbers: 20310140, 20910540, and 20910541. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual unit or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.)
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
  • Product Description
    Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
  • Manufacturer
    Toray Marketing & Sales (America), Inc

Manufacturer

Toray Marketing & Sales (America), Inc
  • Manufacturer Address
    Toray Marketing & Sales (America), Inc, 140 Cypress Station Dr Ste 210, Houston TX 77090-1627
  • Source
    USFDA