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Industry News

• FDA: 15,960 RENASYS NPWT Power Supply Unit Recalled by Smith & Nephew
• 12/09/2018
• 
  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=151851
  
  

  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/ Manufacturer	Smith & Nephew, Inc.
  Manufacturer Reason for Recall	Device may display a battery missing error.
  FDA Determined Cause	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