BEUDAMED
    FDA Recall 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 · Initiated April 7, 2014

    Recall

    Recall Number
    Z-1527-2014
    Event Number
    67950
    Firm
    Laurimed LLC
    FEI Number
    3007209822
    Product Code
    ERL
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 7, 2014
    Posted
    April 30, 2014
    Terminated
    May 14, 2014
    Address
    500 Arguello St, Redwood City, CA, 94063-1566

    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.

    Action

    All direct accounts were notified on April 8, 2014 with an Urgent: Medical Device Recall of PolypVac Microdebrider letter, sent by first class mail. The letter identified the affected product, the reason for the recall, and stated that the firm is in the process of implementing corrections. The firm is requesting that all unused lots be returned to them. Replacement devices will sent to customers. In addition, customers are to complete the attached Lot Information sheet. Questions should be directed to [email protected] or 650-587-5296.

    Distribution

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

    Quantity

    58