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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Mitek FMS Outflow Tubing with OneWay valve

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  Class 2 Device Recall DePuy Mitek FMS Outflow Tubing with OneWay valve see related information
Date Initiated by Firm August 29, 2013
Date Posted November 08, 2013
Recall Status1 Terminated 3 on May 12, 2016
Recall Number Z-0192-2014
Recall Event ID 66145
510(K)Number K002040  K954465  
Product Classification Arthroscope - Product Code HRX
Product DePuy Mitek FMS Outflow Tubing with One-Way valve
Product Code:284649

Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing integrates several functional components including: luer locks for attaching the tube to the Inflow tubing and sheath, clamps, and a one-way valve. The FMS Outflow Tubing with One-Way valve is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy.
Code Information All lot codes
Recalling Firm/
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Drive
Raynham MA 02767-5199
For Additional Information Contact
Manufacturer Reason
for Recall
Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
FDA Determined
Cause 2
Component change control
Action DePuy Mitek inititaed telephone notification on Ausgust 29, 2013 and sent an Urgent Voluntary Product Recall letter dated September 5, 2013 to US and OUS affected customers/affiliates. The customers were notified of the affected products, problem and actions to be taken. The customers were instructed to immediately check all inventories to locate and return affected product following the enclosed instructions. Stericycle is cooridianting the returns. If you have any questions or concerns in regards to this recall, please contact Stericycle directly at 1-866-737-1928.
Quantity in Commerce 29280 units
Distribution Worldwide Distribution - USA (Nationwide) and in the countries of: Australia , Austria , Belgium , Canada , Czech Republic , Denmark , Finland , France, Germany , India, Ireland , Israel, Italy , Latvia , Netherlands , Norway , Nepal, Poland , Portugal , Spain , Sweden , Switzerland , United Kingdom.
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 = FUTURE MEDICAL SYSTEMS, INC.