Events

Recall of Device Recall pO2 D999 membrane units

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
    67044
  • Event Risk Class
    Class 2
  • Event Number
    Z-0713-2014
  • Event Initiated Date
    2013-06-10
  • Event Date Posted
    2014-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124601
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Reason
    Radiometer became aware that the regarded lot po2 units 942-042r0971 were produced with inner solution for pco2 membrane units. this solution is a salt solution similar to the po2 inner solution, but also contains glycerol which can be reduced at the cathode causing a suddenly rising zero current, causing the membrane unit to fail the following cal2 calibration.
  • Action
    Radiometer sent a Product Notification letter dated June 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory and remove any affected product, discard all affected product in their possession, and complete page 2 of the letter and return to their Radiometer representative. Radiometer will replace any quantity of affected product they have at their location. Customers with questions were instructed to contact Radiometer America Technicial Support at 1-800-736-0600, opt 4. For questions regarding this recall call 440-871-8900, ext 209.

Device

Device Recall pO2 D999 membrane units
  • Model / Serial
    Part #: 942-042, Lot #: R0971
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including states of: CO, CT, GA, MA, MO & MS and country of: Canada.
  • Product Description
    pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 || pO2 membrane units, ordering number 942-042 Intended use is in vitro testing of samples of whole blood for pO2 (partial pressure of oxygen).
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA