Events

Recall of Device Recall D711, Reference Membranes, REF 942058

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
    35665
  • Event Risk Class
    Class 3
  • Event Number
    Z-1319-06
  • Event Initiated Date
    2005-06-17
  • Event Date Posted
    2006-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46581
  • 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
    in vitro diagnostic - Product Code CHL
  • Reason
    The recalled membranes cause the status value of the ph and electrolyte electrodes to be offset causing readings outside of the acceptable range.
  • Action
    The recalling firm notified their distributor/customers of this recall, via telephone on 6/17/2005, at which time, the customers were asked to destroy any and all suspect reference membranes found on-site and at their subaccount customer locations.

Device

Device Recall D711, Reference Membranes, REF 942058
  • Model / Serial
    Lot Code: R0308, Expiration Date: 4/07; Lot Code: R0309, Expiration Date: 5/07; and Lot Code: R0310, Expiration Date: 5/07.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including TX, OK, MI, CO, NY, and Canada.
  • Product Description
    D711, Reference Membranes, Part #942-058, used with the ABL835 Blood Gas Analyzers.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA