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U.S. Department of Health and Human Services

Class 2 Device Recall RENASYS GO Negative Pressure Wound Therapy

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  Class 2 Device Recall RENASYS GO Negative Pressure Wound Therapy see related information
Date Initiated by Firm November 11, 2016
Create Date January 18, 2017
Recall Status1 Open3, Classified
Recall Number Z-1041-2017
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, 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. 66800164; All pumps of this model are affected.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
970 Lake Carillon Dr Ste 110
Saint Petersburg FL 33716-1130
For Additional Information Contact Customer Care Center
727-392-1261
Manufacturer Reason
for Recall		 Lack of 510k clearance for design modification.
FDA Determined
Cause 2		 No Marketing Application
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 in the US
Distribution Nationwide
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OMP and Original Applicant = SMITH & NEPHEW, INC.
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