BEUDAMED
    FDA Recall Terminated

    Conformer - Large with holes (Sterile)

    Recall: Z-0539-03 · Initiated November 29, 2002

    Recall

    Recall Number
    Z-0539-03
    Event Number
    25123
    Firm
    Gulden Ophthalmics
    FEI Number
    2518410
    Product Code
    HQX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 29, 2002
    Posted
    February 5, 2003
    Terminated
    February 6, 2004
    Address
    225 Cadwalader Ave, Elkins Park, PA, 19027-2020

    Description

    Conformer - Large with holes (Sterile)

    Reason

    lack of sterility assurance

    Action

    The recalling firm issued letters to the accounts requesting the return of the devices.

    Distribution

    Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand