BEUDAMED
    FDA Recall Terminated

    ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.

    Recall: Z-1320-06 · Initiated June 9, 2005

    Recall

    Recall Number
    Z-1320-06
    Event Number
    35774
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 9, 2005
    Posted
    August 3, 2006
    Terminated
    February 24, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    ABL 5 Capillary Adaptor (a connection that fits the capillary tube on to the aspirator on the ABL 5 & BPH 5 Analyzers), in vitro diagnostic accessory, Part Number: 906-018.

    Reason

    The dimensions and shape of the analyzer adaptor do not fit the analyzer tubes or probe, causing air to be aspirated with the blood sample and causing a deviation in the pO2 sample results.

    Action

    The firm issued a letter to their customers dated 6/9/2005. The letter reports the defect with the ABL5 Capillary Adapters and informs the customers that Radiometer reps will be replacing all of the customers'' ABL5 adaptors ASAP. The letter is accompanied by a single bag of new adaptors for the customers'' ''immediate needs'' and also provides a faxed response form which the customer can use to request additional adapters as required. In addition, should the customer choose to use the old adapters in their possession, the letter stresses and reiterates the ''Precautions and Warnings'' applicable for use of the ABL5 should air bubbles be observed in the measuring chamber by the user/operator.

    Distribution

    Nationwide, including KS, OH, MD, FL, TX, CA, KY, MA, VA, WA, IL, AR and ME, and Canada.

    Quantity

    155 bags