BEUDAMED
    FDA Recall Open, Classified

    Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.

    Recall: Z-1041-2017 · Initiated November 11, 2016

    Recall

    Recall Number
    Z-1041-2017
    Event Number
    75966
    Firm
    Smith & Nephew, Inc.
    FEI Number
    3006760724
    Product Code
    OMP
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    November 11, 2016
    Address
    970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, 33716-1130

    Description

    Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.

    Reason

    Lack of 510k clearance for design modification.

    Action

    On letter sent to all their consignees, Smith & Nephew asked to the consignees to removed all existing Renasys Go NPWT Pumps and returned following the instructions on the letter and also removed the affected power supply units identified on the recall letter. Each consignee needs to complete the Acknowledge

    Distribution

    Nationwide

    Quantity

    15,960 units in the US