BEUDAMED
    FDA Recall Terminated

    Peregrine 20 GA Endo Ocular Adjustable Laser Probe

    Recall: Z-2399-2010 · Initiated July 19, 2010

    Recall

    Recall Number
    Z-2399-2010
    Event Number
    56271
    Firm
    Peregrine Surgical Ltd
    FEI Number
    1000121498
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 19, 2010
    Posted
    September 11, 2010
    Terminated
    September 30, 2010
    Address
    51 Britain Dr, New Britain, PA, 18901-5186

    Description

    Peregrine 20 GA Endo Ocular Adjustable Laser Probe

    Reason

    Product did not have proper 510(k) clearance

    Action

    A recall letter is being sent to all affected accounts with instructions to return the recalled product to the recalling firm.

    Distribution

    Product was distributed to hospitals and eye surgery centers in Florida, Maryland, Missouri, North Carolina, Ohio, Pennsylvania, Texas.

    Quantity

    132 boxes