BEUDAMED
    FDA Recall Terminated

    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.

    Recall: Z-0360-2014 · Initiated November 1, 2013

    Recall

    Recall Number
    Z-0360-2014
    Event Number
    66720
    Firm
    SALTER LABS
    FEI Number
    1314417
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    November 1, 2013
    Posted
    November 19, 2013
    Terminated
    December 17, 2013
    Address
    100 Sycamore Rd, Arvin, CA, 93203-2300

    Description

    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.

    Reason

    It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.

    Action

    Salter Labs called the five customers that received product from the three lots, then follow-up immediately by sending a recall notification letter directly to each customer. Each letter will identify all shipments of subject product that they received. All customers letters were sent certified mail, return receipt requested.

    Distribution

    Distributed in the states of MS, TX FL,, WI, MI, VA, NY, MO, NC, and MS.

    Quantity

    91 cases (25 units per case)