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  • FDA: 15,960 RENASYS NPWT Power Supply Unit Recalled by Smith & Nephew
  • 12/09/2018


    Date Initiated by Firm November 11, 2016
    Create Date January 18, 2017
    Recall Status Open, Classified
    Recall Number Z-1042-2017
    Recall Event ID 75966
    510(K)Number K083375
    Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
    Product Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, 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.
    Code Information Model No. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875.
    Recalling Firm/
    Smith & Nephew, Inc.
    Manufacturer Reason
    for Recall
    Device may display a battery missing error.
    FDA Determined
    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.
    Quantity in Commerce 15,960 units (US)
    Distribution US Nationwide

    1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
    2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
    3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

    Last Updated: Sept. 12th, 2018

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