BEUDAMED
    FDA Recall Terminated

    Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA

    Recall: Z-0843-2008 · Initiated October 11, 2007

    Recall

    Recall Number
    Z-0843-2008
    Event Number
    45812
    Firm
    Nonin Medical, Inc
    FEI Number
    2183646
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 11, 2007
    Posted
    April 11, 2008
    Terminated
    December 18, 2011
    Address
    13700 1st Ave N, Plymouth, MN, 55441-4595

    Description

    Nonin Model 2500 PalmSAT handheld pluse Oximeter , Nonin Medical, Inc., Plymouth, MN USA

    Reason

    Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.

    Action

    An Urgen Field Action letters was sent (10/11/07) to Nonin distributors who received the potentially mislabeled product. The letters provided labeling differences and included instructions for notifying their customers, with a response form to be returned to Nonin. For additional information please contact Kim Aves at 763-577-3196.

    Distribution

    Worldwide Distribution ---- USA including states of ME, SC, SD, CA, MO, NY, MI, FL, IL, PA, NC, CT, and TX, and countries of Canada, Greece, Russia, Italy, Sweden, Australia, & Japan.

    Quantity

    240