BEUDAMED
    FDA Recall Terminated

    SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then multi-packed, 20 per shelf-box.

    Recall: Z-0901-2015 · Initiated November 25, 2014

    Recall

    Recall Number
    Z-0901-2015
    Event Number
    70045
    Firm
    Nonin Medical, Inc
    FEI Number
    2183646
    Product Code
    DQA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 25, 2014
    Posted
    December 31, 2014
    Terminated
    September 1, 2015
    Address
    13700 1st Ave N, Plymouth, MN, 55441-4595

    Description

    SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 9705-001, 4-Wavelength), with associated materials (INT-100 cable, operator's manual; and Quick Start Guide). Sensors are single-packed in a pouch, then multi-packed, 20 per shelf-box.

    Reason

    Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.

    Action

    Consignees were sent a Nonin letter dated November 24, 2014. The letter described the problem and the product affected. They requested consignees to discontinue the use of the products and return it to Nonin. Consignees were asked to complete and return the "Medical Device Market Withdrawal Return Response Form". For questions and additional information they can contact James H. Russell at 763-577-2260 or e-mail [email protected].

    Distribution

    To be provided later.

    Quantity

    5892 (5452 US, 440 OUS)