Events

Recall of Device Recall Instrumentation Laboratory (IL)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instrumentation Laboratory Co..

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
    25810
  • Event Risk Class
    Class 2
  • Event Number
    Z-0846-03
  • Event Initiated Date
    2003-03-07
  • Event Date Posted
    2003-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26508
  • 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
    Incorrect bar code applied to cartridges could result in inaccurate po2 value.
  • Action
    IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.

Device

Device Recall Instrumentation Laboratory (IL)

Manufacturer

Instrumentation Laboratory Co.
  • Manufacturer Address
    Instrumentation Laboratory Co., 113 Hartwell Avenue, Lexington MA 02173
  • Source
    USFDA