BEUDAMED
    FDA Recall Terminated

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    Recall: Z-1044-2016 · Initiated November 11, 2015

    Recall

    Recall Number
    Z-1044-2016
    Event Number
    72823
    Firm
    ConvaTec, Inc
    FEI Number
    3011987967
    Product Code
    LCQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 11, 2015
    Posted
    March 3, 2016
    Terminated
    July 18, 2016
    Address
    7900 Triad Center Dr, Ste 400, Greensboro, NC, 27409-9076

    Description

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    Reason

    The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.

    Action

    The firm, ConvaTec, sent each consignee affected by the recall an overnight express mail "Urgent Voluntary Recall Notice" and Response Form dated 12/7/2015. The notice described the product, problem and actions to be taken. The recall notice instructed the consignee to immediately stop distributing and quarantine all affected lots; perform a count of all recalled product currently in inventory; complete and return the enclosed Recall Response Form by email at [email protected] or by fax at 1-888-603-8986, and return all affected product, (ONLY return the lots affected with this recall). If you want replacement product contact customer service by phone at 1-800-634-6003, extension 1103 or by email at [email protected]. If you have any questions call 1-877-650-3492.

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, ME, MA, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TX VA, WA, WI, and countries of: Australia, Belgium, Burma, Canada, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Netherlands, Norway, Russia, Saudi Arabia, Sweden, Switzerland, United Kingdom & Vietnam.

    Quantity

    3,605,700 pieces