BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1067-2014 · Initiated November 14, 2013

    Recall

    Recall Number
    Z-1067-2014
    Event Number
    66893
    Firm
    Smith & Nephew Inc.
    FEI Number
    3006760724
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 14, 2013
    Posted
    February 21, 2014
    Terminated
    August 4, 2014
    Address
    970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, 33716-1130

    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.

    Action

    The correction strategy is as follows: " An Urgent Medical Device Correction Notice has been prepared to be distributed to all US consignees via Federal Express delivery for confirmation of the delivery. " A copy of the Urgent Medical Device Correction Notice is to be posted on Smith & Nephew's websites, URL corporate, http://www.smith-nephew.com/news-and-media/, and myrenasys.com, concurrent with the distribution of the Notice to consignees. " US distribution of the original design of Canister Kits codes (66800912, 66800913, 66801066, 66800423 and 66800058) subject to this correction ceased November 1, 2013. " The correction has been implemented on a change being affected basis. The modified design is being distributed to US customers effective November 1, 2013. No product will be removed from the market. " Periodic progress reports to FDA, as required per 21 CFR 806 will be submitted monthly until completion of the correction actions..

    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