BEUDAMED
    FDA Enforcement Class II Terminated

    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

    Recall: Z-0041-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0041-2015
    Event ID
    69146
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2014
    Initiation Date
    July 18, 2014
    Classification Date
    October 8, 2014
    Termination Date
    August 5, 2015
    Address
    970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, 33716-1130, United States

    Description

    RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

    Reason

    RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.

    Code Info

    Item 66800912 Lot # M400071

    Distribution

    Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.

    Quantity

    45,466