BEUDAMED
    FDA Recall Terminated

    S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.

    Recall: Z-1460-06 · Initiated October 31, 2005

    Recall

    Recall Number
    Z-1460-06
    Event Number
    35663
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2005
    Posted
    August 29, 2006
    Terminated
    April 17, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers.

    Reason

    Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution.

    Action

    Representatives of the recalling firm were informed of this problem and were asked to visit the firm''s customers and retrieve any of the suspect product found in inventory at each customer location for customer credit. The representatives were instructed to complete this action via a ''Management Cover e-mail issued on 10/31/2005. According to the Management Cover Memo, these actions were scheduled for completion by firm representatives on or before 12/15/2005.

    Distribution

    The recalled product was distributed to customers in following states nationwide: AL, AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV and WY

    Quantity

    638/200 mL plastic bottles.