BEUDAMED
    FDA Recall Terminated

    ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system

    Recall: Z-0104-04 · Initiated September 24, 2003

    Recall

    Recall Number
    Z-0104-04
    Event Number
    27519
    Firm
    Sandhill Scientific, Inc
    FEI Number
    2023374
    Product Code
    FFT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2003
    Posted
    November 11, 2003
    Terminated
    November 17, 2003
    Address
    9150 Commerce Center Cir, Ste 500, Highlands Ranch, CO, 80129-1563

    Description

    ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system

    Reason

    Pouch containing pediatric probes was labeled as containing adult probes.

    Action

    The 3 consignees were notified by telephone on 09/24/2003, followed by a letter.

    Distribution

    CO, MT, TX.

    Quantity

    17 probes