Events

Recall of Disposable Waste Container

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer 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
    51986
  • Event Risk Class
    Class 2
  • Event Number
    Z-1554-2009
  • Event Initiated Date
    2009-04-16
  • Event Date Posted
    2009-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81840
  • 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
    Container, empty, for collection & processing of blood & blood components - Product Code CHL
  • Reason
    When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
  • Action
    Radiometer America Inc. issued a recall notification letter dated May 5, 2009 to all customers containing information on replacement of all potentially defective waste containers and instruction on how to handle any mounted waste containers. For further questions, contact Radiometer America Inc. at 1-800-736-0600.

Device

Disposable Waste Container
  • Model / Serial
    Part Number: 905-590; Article Number: D512; Lot Numbers: WR-01, WR-02, WR-03, WS-01, WS-02, WS-03, WU-01, WU-02 and WU-03.  Part Number 905-802; Article Number: D513; Lot Numbers: WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WS-04, WU-01, WU-02, WU-03, WU-04, WU-05, WU-06 and WY-01.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to US and Canada.
  • Product Description
    Waste bottles Part Numbers/Article Numbers: 905-590/D512 and 905-802/D513. || The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA