Z-0192-2014 Class II Terminated
FDA device recall Z-0192-2014 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Aug 29, 2013 and is designated Class II. 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… The recall status is terminated (terminated May 12, 2016). Affected quantity: 29280 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 20, 2013
- Initiation Date
- Aug 29, 2013
- Termination Date
- May 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29280 units
Product 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.
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
Distribution pattern
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.
Code information
All lot codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0192-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026