BEUDAMED
    FDA Recall Terminated

    RENASYS EZ/ RENASYS EZ Plus 800 mL canister 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-0040-2015 · Initiated July 18, 2014

    Recall

    Recall Number
    Z-0040-2015
    Event Number
    69146
    Firm
    Smith & Nephew, Inc.
    FEI Number
    3006760724
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 18, 2014
    Posted
    October 8, 2014
    Terminated
    August 5, 2015
    Address
    970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, 33716-1130

    Description

    RENASYS EZ/ RENASYS EZ Plus 800 mL canister 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.

    Action

    Smith & Nephew sent an Urgent Medical Device Correction Notice dated July 15, 2014 to all US customers via Federal Express delivery. The letter identified the affected product, problem and actions to be taken. The firm instructed customers to discard the affected product and replace with a new one from an unaffected lot. For questions contact 727-399-3785.

    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

    77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066))