BEUDAMED
    FDA Recall Terminated

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    Recall: Z-2093-2014 · Initiated June 25, 2014

    Recall

    Recall Number
    Z-2093-2014
    Event Number
    68701
    Firm
    Salter Labs
    FEI Number
    1314417
    Product Code
    BYG
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 25, 2014
    Posted
    July 23, 2014
    Terminated
    September 10, 2014
    Address
    2365 Camino Vida, Carlsbad, CA, 92011

    Description

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    Reason

    The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.

    Action

    Salter Labs sent a Medical Device Recall letter dated June 25, 2014 to all affected customers. The letter identified the affected product, problems and actions to be taken. Customers are instructed to complete the attached Return Response Form and return it to Salter as soon as possible. Customers are instructed to send completed form to Salter by either Fax (800) 628-4690, attn: Sarah Velasquez, email to [email protected], or mail to Salter Labs, attn: Sarah Velasquez, 100 W. Sycamore Rd. Arvin, CA 93203.

    Distribution

    Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.

    Quantity

    584 units