BEUDAMED
    FDA Recall Terminated

    8500M Handheld Pulse Oximeter

    Recall: Z-1690-2017 · Initiated September 29, 2016

    Recall

    Recall Number
    Z-1690-2017
    Event Number
    75424
    Firm
    Nonin Medical, Inc
    FEI Number
    2183646
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 29, 2016
    Terminated
    March 12, 2018
    Address
    13700 1st Ave N, Plymouth, MN, 55441-4595

    Description

    8500M Handheld Pulse Oximeter

    Reason

    Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.

    Action

    Consignees were called and sent on 9-29-2016 a Nonin Urgent Medical Device Recal" letter dated 29 September, 2016. The letter described the problem and the product involved in the recall. Additionally, it described the Potential Risk and Required Action. Requested consignees to return the affected units and to forward the contact information if the unit is no longer in their inventory. For questions contact [email protected] or via direct telephone at 763 577 3196.

    Distribution

    Distribution in US (MI, NC, OH, NC, VA), and CANADA

    Quantity

    15 (11 US; 4 OUS)