BEUDAMED
    FDA Enforcement Class II Terminated

    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

    Recall: Z-1067-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1067-2014
    Event ID
    66893
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    November 14, 2013
    Classification Date
    February 21, 2014
    Termination Date
    August 4, 2014
    Address
    970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, 33716-1130, United States

    Description

    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

    Reason

    Modification of the bacterial overflow guard (filter) and related changes to product labeling.

    Code Info

    Product code: 66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299

    Distribution

    Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.

    Quantity

    6,799,140 canisters EZ & EZ PLUS