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DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FM
Recalled November 20, 2013 · FDA recall Z-0192-2014 · DePuy Mitek, Inc., a Johnson & Johnson
Hazard
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 Class II
Units
29280 units
Sold at
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.
Description
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
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.
Manufacturer(s)
DePuy Mitek, Inc., a Johnson & Johnson Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →