BEUDAMED
    FDA Enforcement Class III Terminated

    PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

    Recall: Z-1527-2014 · Reported May 7, 2014

    Enforcement

    Recall Number
    Z-1527-2014
    Event ID
    67950
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Laurimed LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2014
    Initiation Date
    April 7, 2014
    Classification Date
    April 30, 2014
    Termination Date
    May 14, 2014
    Address
    500 Arguello St, Redwood City, CA, 94063-1566, United States

    Description

    PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

    Reason

    The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.

    Code Info

    Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.

    Distribution

    Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.

    Quantity

    58