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U.S. Department of Health and Human Services

Class 2 Device Recall RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ)

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  Class 2 Device Recall RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) see related information
Date Initiated by Firm August 13, 2014
Date Posted September 23, 2014
Recall Status1 Terminated 3 on August 06, 2015
Recall Number Z-2688-2014
Recall Event ID 69137
510(K)Number K082426  
Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
Product RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
Code Information Model #'s 66800059, all lots since product launched 01/16/2009
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
970 Lake Carillon Dr
Ste 110
Saint Petersburg FL 33716-1130
For Additional Information Contact
800-876-1261
Manufacturer Reason
for Recall		 Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
FDA Determined
Cause 2		 No Marketing Application
Action All RENASYS EZ Products will be removed from the field and customers will be transitioned to other product. On August 13, 2014 the firm sent an "Urgent- Medical Device Removal RENASYS EZ" notification via FedEx overnight asking that the use of the RENASYS EZ should be immediately discontinued and the device should be returned to Smith & Nephew. If you have questions, please reach out to your Customer Care representative or call 1-800-876-1261 Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time.
Quantity in Commerce 2,142 units
Distribution Worldwide Distribution- US (nationwide) including MA, MN, NY and Puerto Rico; Canada, Mexico, Dubai, Australia, Chile, Colombia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OMP and Original Applicant = SMITH & NEPHEW, INC.
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