BEUDAMED
    FDA Enforcement Class II Terminated

    Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.

    Recall: Z-1683-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1683-2017
    Event ID
    76725
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    National Biological Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 5, 2017
    Initiation Date
    January 27, 2017
    Classification Date
    March 24, 2017
    Termination Date
    February 8, 2019
    Address
    23700 Mercantile Rd, Beachwood, OH, 44122-5900, United States

    Description

    Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.

    Reason

    The wiring may allow the lamps to turn on with the key switch rather than the timer.

    Code Info

    Serial numbers: 39870, 39873, 39874, 39866, 39867, 39871, 39869

    Distribution

    Worldwide distribution. US states: IA, IL, MI, NY, PA, and WI. Country: Jordan. There are no government accounts for this recall. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.

    Quantity

    7 units