Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall RENASYS GO Negative Pressure Wound Therapy External Power Supply Unitsee related information
Date Initiated by FirmNovember 11, 2016
Create DateJanuary 18, 2017
Recall Status1 Open3, Classified
Recall NumberZ-1042-2017
Recall Event ID 75966
510(K)NumberK083375 
Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
ProductSmith & 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.
970 Lake Carillon Dr Ste 110
Saint Petersburg FL 33716-1130
For Additional Information ContactCustomer Care Center
727-392-1261
Manufacturer Reason
for Recall		Lack of 510k clearance for design modification.
FDA Determined
Cause 2		No Marketing Application
ActionOn 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 Commerce15,960 units (US )
DistributionNationwide
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = OMP
-
-