BEUDAMED
    FDA Enforcement Class II 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 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1995-2016
    Event ID
    74197
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    FSC Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    May 16, 2016
    Classification Date
    June 15, 2016
    Termination Date
    February 10, 2017
    Address
    6000 Fairview Rd Ste 600, Charlotte, NC, 28210-2201, United States

    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.

    Code Info

    Lot 5295 (trade) NDC 13551-901-01; Lot 5313 (demonstration units) and 5325 NDC 13551-902-01

    Distribution

    US Nationwide distribution.

    Quantity

    1435 units