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U.S. Department of Health and Human Services

Class 2 Device Recall RENASYS

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  Class 2 Device Recall RENASYS see related information
Date Initiated by Firm July 18, 2014
Date Posted October 08, 2014
Recall Status1 Terminated 3 on August 05, 2015
Recall Number Z-0041-2015
Recall Event ID 69146
510(K)Number K102001  K082426  
Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
Product RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier

Product Usage:
RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Code Information Item 66800912 Lot # M400071
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
970 Lake Carillon Dr
Ste 110
Saint Petersburg FL 33716-1130
For Additional Information Contact
727-392-1261
Manufacturer Reason
for Recall		 RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid.
FDA Determined
Cause 2		 Device Design
Action Smith & Nephew sent an Urgent Medical Device Correction Notice dated July 15, 2014 to all US customers via Federal Express delivery. The letter identified the affected product, problem and actions to be taken. The firm instructed customers to discard the affected product and replace with a new one from an unaffected lot. For questions contact 727-399-3785.
Quantity in Commerce 45,466
Distribution Worldwide Distribution - US Nationwide in the states of FL, NC, CA, MO, MA, TX, NY, OH, CO, VA, IL, NJ, TN, NV, MN including Puerto Rico and countries of Canada, Mexico, Dubai, Argentina, Australia, Colombia, Germany, Hong Kong, Jordon, Malaysia, Thailand, Tunisia, New Zealand, South Africa, Shanghai, Brazil, Saudi Arabia and Lebanon.
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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