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.
Recall
- Recall Number
- Z-0192-2014
- Event Number
- 66145
- Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- FEI Number
- 1221934
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- August 29, 2013
- Posted
- November 8, 2013
- Terminated
- May 12, 2016
- Address
- 325 Paramount Drive, Raynham, MA, 02767-5199
Description
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.
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
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.
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.
29280 units