BEUDAMED
    FDA Recall Terminated

    Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008

    Recall: Z-1132-2008 · Initiated January 8, 2008

    Recall

    Recall Number
    Z-1132-2008
    Event Number
    46741
    Firm
    Keeler Instruments Inc
    FEI Number
    2519784
    Product Code
    HLI
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 8, 2008
    Posted
    May 22, 2008
    Terminated
    August 12, 2008
    Address
    456 Parkway, Broomall, PA, 19008

    Description

    Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008

    Reason

    Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.

    Action

    Keeler Instruments issued an email dated 1/8/08 to the distributor requesting that they return the product.

    Distribution

    The products were shipped to a distributor in NJ.

    Quantity

    25 units