BEUDAMED
    FDA Recall Terminated

    ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company

    Recall: Z-1173-2007 · Initiated June 19, 2007

    Recall

    Recall Number
    Z-1173-2007
    Event Number
    38359
    Firm
    Sendx Medical Inc
    FEI Number
    2027541
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 19, 2007
    Posted
    August 18, 2007
    Terminated
    November 7, 2011
    Address
    1945 Palomar Oaks Way, Carlsbad, CA, 92009-1307

    Description

    ABL77 Cal Pack, Model Number 944-069, Lot Number 17323, SenDx Medical Inc., A Radiometer Company

    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.

    Distribution

    Worldwide Distribution --- USA including state of OH and countries of China, Denmark Latvia, Mexico & Spain.

    Quantity

    69