BEUDAMED
    FDA Recall Terminated

    HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton Each kit contains 100 tab electrodes and 26 alcohol pads. The electrodes are used to measure bodyfat analysis. The alcohol pads (non-sterile) are used for cleaning the skin to help the electrodes adhere better. There are no instructions for use with the kit.

    Recall: Z-2136-2011 · Initiated February 8, 2011

    Recall

    Recall Number
    Z-2136-2011
    Event Number
    58052
    Firm
    Vermed, Inc.
    FEI Number
    1317188
    Product Code
    IKD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 8, 2011
    Posted
    May 4, 2011
    Terminated
    July 25, 2011
    Address
    9 Lovell Dr., Bellows Falls, VT, 05101

    Description

    HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton Each kit contains 100 tab electrodes and 26 alcohol pads. The electrodes are used to measure bodyfat analysis. The alcohol pads (non-sterile) are used for cleaning the skin to help the electrodes adhere better. There are no instructions for use with the kit.

    Reason

    Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination.

    Action

    Vermed sent consignee a recall notification letter on February 8, 2011, followed by a phone call and email. The consignee was instructed to respond with a Recall Reply Form via fax and to notify any customers to whom the affected product was further distributed. All recalled alcohol prep pads were to be returned to Triad Group. Firm is replacing Triad alcohol pads in kits with pads from another supplier and has removed Triad from its approved vendor list. For questions regarding this recall call 802-722-9976.

    Distribution

    OR

    Quantity

    2500 kits total; 500 from each lot except 1000 from Lot 203031