BEUDAMED
    FDA Recall Terminated

    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

    Recall: Z-1995-2016 · Initiated May 16, 2016

    Recall

    Recall Number
    Z-1995-2016
    Event Number
    74197
    Firm
    FSC Laboratories, Inc
    FEI Number
    3008832322
    Product Code
    NVP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 16, 2016
    Posted
    June 15, 2016
    Terminated
    February 10, 2017
    Address
    6000 Fairview Rd, Ste 600, Charlotte, NC, 28210-2201

    Description

    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

    Reason

    Product had torn/loose seal around the mouthpiece.

    Action

    Letters were sent to consignees on 5/16/2016 informing them of the recall and requesting that they immediately discontinue use of the product. The letter included a reply form to be returned to FSC Laboratories.

    Distribution

    US Nationwide distribution.

    Quantity

    1435 units