Events

Recall of Device Recall Radiometer Copenhagen ABL77 Cal Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sendx Medical 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
    38359
  • Event Risk Class
    Class 2
  • Event Number
    Z-1173-2007
  • Event Initiated Date
    2007-06-19
  • Event Date Posted
    2007-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53481
  • 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
    Error in the ca12 calibration value for pco2 recorded in the cal pack barcode for lot 17323. this error will result in falsely elevated pco2 results at the high end of the measuring range.
  • Action
    A total of four (4) distributors were sent the recall package (Field Action Notice) by email on 6-29-07. The distributors were provided background information and specific instruction that all Cal packs from lot 17323 should be removed from customer sites and destroyed. The Recall package included a Management Cover for Field Action Notes, a Customer Letter and the Field Action Notice #915-261. All communications regarding field actions associated with this recall were distributed using the Radiometer Field Action Note (FAN) system.

Device

Device Recall Radiometer Copenhagen ABL77 Cal Pack
  • Model / Serial
    Lot Number 17323
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including state of OH and countries of China, Denmark Latvia, Mexico & Spain.
  • Product Description
    ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company
  • Manufacturer
    Sendx Medical Inc

Manufacturer

Sendx Medical Inc
  • Manufacturer Address
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92009-1307
  • Source
    USFDA