DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649… — Class II medical device recall Z-0192-2014
Terminated recall by DePuy Mitek, Inc., a Johnson & Johnson Co., reported 2013-11-20, distributed nationwide. Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perfo
| Recall number | Z-0192-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co., Raynham, MA, United States |
| Recall initiated | 2013-08-29 |
| Classified | 2013-11-08 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2016-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IN, IT, LV, NL, NO, NP, PL, PT, SE |
| Quantity | 29,280 units |
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.
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.