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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 Single Suction

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 Class 2 Device Recall DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suctionsee related information
Date Initiated by FirmMay 27, 2009
Date PostedSeptember 21, 2009
Recall Status1 Terminated 3 on May 08, 2012
Recall NumberZ-2077-2009
Recall Event ID 52211
510(K)NumberK051326 
Product Classification Arthroscope - Product Code HRX
ProductDYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005
Code Information Lot Numbers: 0149J, 0149H, 0149K, 0769P, 0799N, 0899K, 0919K, 09609W, 1688L, 1788H, 1798F, 1918F, 1928H, 1928HR, 1998X, 2218H, 2258F, 2278F, 2328H, 2388J, 2398F, 2418T, 2478K, 2758U, 2758Y, 2758Y, 2778F, 2778FR, 2898F, 2908X, 2908Y, 3048N, 3098F, 3258U, 3258V, 3468U, and 3468V. 
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information ContactPundit Tiwari
978-749-1073
Manufacturer Reason
for Recall		The sterility of the device cannot be assured
FDA Determined
Cause 2		Package design/selection
ActionSmith & 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 Commerce67,697 units
DistributionWorldwide 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HRX
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