BEUDAMED
    FDA Enforcement Class II 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 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0360-2014
    Event ID
    66720
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SALTER LABS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 27, 2013
    Initiation Date
    November 1, 2013
    Classification Date
    November 19, 2013
    Termination Date
    December 17, 2013
    Address
    100 Sycamore Rd, Arvin, CA, 93203-2300, United States

    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.

    Code Info

    Model number: 4515-15-25; lot numbers 071513, 071513A and 120312.

    Distribution

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

    Quantity

    91 cases (25 units per case)