BEUDAMED
    FDA Recall Terminated

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    Recall: Z-2486-2015 · Initiated August 31, 2013

    Recall

    Recall Number
    Z-2486-2015
    Event Number
    71803
    Firm
    Physician Engineered Products, Inc.
    FEI Number
    2183604
    Product Code
    LBI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 31, 2013
    Posted
    August 31, 2015
    Terminated
    September 2, 2015
    Address
    103 Smith St, Fryeburg, ME, 04037-1182

    Description

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    Reason

    Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions

    Action

    Physician Engineered Products, Inc. sent an Bright Embrace Recall notification dated September 10, 2013, to notify customers of the recall of the Bright Embrace . PEP is issuing a Return Authorization to you. Upon receipt PEP will reimburse to you: 1) The cost of the device(s) 2) Shipping costs-both from and to PEP For further questions please call (207) 935-1256.

    Distribution

    Worldwide Distribution - US Distribution to the states of : CA, CO, FL, KY, MA, MD, NM, PA, TN, TX and VA., and to the countries of : Egypt, Honduras, Saudi Arabia and Singapore.

    Quantity

    97 units