BEUDAMED
    FDA Recall 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 · Initiated January 27, 2017

    Recall

    Recall Number
    Z-1683-2017
    Event Number
    76725
    Firm
    National Biological Corp
    FEI Number
    1521608
    Product Code
    FTC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 27, 2017
    Posted
    March 20, 2017
    Terminated
    February 8, 2019
    Address
    23700 Mercantile Rd, Beachwood, OH, 44122-5900

    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.

    Action

    Individual patients were contacted via telephone. Replacement devices have been distributed. The distributor was contacted via email. The firm has requested that consignees return the recalled device to their firm to be held under quarantine.

    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