BEUDAMED
    FDA Recall Terminated

    ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Salter Labs 100 W. Sycamore Road, Arvin, CA 93203

    Recall: Z-0605-2012 · Initiated December 7, 2011

    Recall

    Recall Number
    Z-0605-2012
    Event Number
    60658
    Firm
    SALTER LABS
    FEI Number
    1314417
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 7, 2011
    Posted
    January 11, 2012
    Terminated
    January 9, 2012
    Address
    100 Sycamore Rd, Arvin, CA, 93203-2300

    Description

    ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal prongs. w/7' O2 line and 7' CO2 line with male luer lock connector. Salter Labs 100 W. Sycamore Road, Arvin, CA 93203

    Reason

    Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).

    Action

    The firm notified the three affected customers directly by phone, followed by a recall form for each direct customer indicating the product, part number, lot number and shipment date and customer order specific for each firm. Customers were to complete and return the form to the fax number listed or call a Customer Service Representative at 1-800-628-4690.

    Distribution

    Nationwide Distribution -- TX and VA.

    Quantity

    240 cases