BEUDAMED
    FDA Recall Terminated

    Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614

    Recall: Z-1188-2008 · Initiated May 18, 2007

    Recall

    Recall Number
    Z-1188-2008
    Event Number
    46397
    Firm
    Kentec Medical Inc
    FEI Number
    2080225
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    May 18, 2007
    Posted
    June 26, 2008
    Terminated
    February 29, 2012
    Address
    17871 Fitch, Irvine, CA, 92614-6001

    Description

    Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care. Kentec Medical Inc., Irvine, CA 92614

    Reason

    Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes.

    Action

    Consignees were notified via telephone on 5/18/07 and an "Important Voluntary Market Withdrawal Notice" letter on 5/23/07. The letter instructed consignees to segregate and return all affected devices. The letter included an "Acknowledgement of Market Withdrawal Notification" form for customer to complete and return to the recalling firm. For additional information, contact 1-800-825-5996.

    Distribution

    Nationwide Distribution including states of AZ, CA, CO, FL, KY, LA, MA, NC, NJ, TX and UT.

    Quantity

    41