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U.S. Department of Health and Human Services

Class 2 Device Recall DYONICS 25 Fluid Management System

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  Class 2 Device Recall DYONICS 25 Fluid Management System see related information
Date Initiated by Firm August 07, 2008
Date Posted September 21, 2008
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-2448-2008
Recall Event ID 49132
510(K)Number K051326  
Product Classification Arthroscope. - Product Code HRX
Product DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for remote Control in a sterile field.
Code Information Lot Numbers: 1548H, 1548J, 1718U, 1758F, 1848U, and 1928F.
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		 Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
FDA Determined
Cause 2		 Packaging process control
Action Smith & Nephew Inc. Endoscopy Division contacted each affected user facility via confirmation letter and phone. An Urgent Product Correcetion Notification was sent on August 7, 2008. Users requested to discard the remote control bag form the kit and alternative suggestions provided. For further information please contact Paul Tiwari at 978-749-1397.
Quantity in Commerce 11,469 units
Distribution Worldwide Distribution including USA and countries of Canada, Chile, Colombia, Greece, France, Australia, Netherlands, South Africa, United Kingdom, Japan, Dubai, Germany, India, Malaysia, Switzerland, Belgium, Italy, and Puerto Rico.
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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