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U.S. Department of Health and Human Services

Class 2 Device Recall DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction

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  Class 2 Device Recall DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction see related information
Date Initiated by Firm May 27, 2009
Date Posted September 21, 2009
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-2078-2009
Recall Event ID 52211
510(K)Number K051326  
Product Classification Arthroscope - Product Code HRX
Product DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction
Catalog Number: 7211006
Code Information 0169H, 0299J, 0409K, 0409L, 0409M, 0479U, 0479X, 0489F, 0489H, 0859F, 0899J, 0919F, 1618F, 1618L, 1618LR, 1628F, 1628FR, 1648K, 1648KR, 1758J,1838K, 1908M, 1938F, 2058L, 2528F, 2528FR, 2558F, 2698J, 2748F, 2748P, 2808U, 2838L, 2848H, 2878N, 2908U, 2908V, 3038N, 3048M, and 3258P.  
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Pundit Tiwari
978-749-1073
Manufacturer Reason
for Recall		 The sterility of the device cannot be assured
FDA Determined
Cause 2		 Package design/selection
Action Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.
Quantity in Commerce 67,697 units
Distribution Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, Puerto Rico, France, Asia Pacific, Belgium, Canada, Norway, Thailand, The Netherlands, Malaysia, Brazil, Argentina, Chile, Colombia, Costa Rica, Venezuela, Turkey, Israel, Germany, UAE, Greece, and South Africa.
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 = HRX and Original Applicant = SMITH & NEPHEW, INC.
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