FDAFDA · Food and drugs·Recall number Z-0191-2014
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 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 Intermediary Tubing is sterile and intended for single use with the FMS Fluid Management Systems in a surgical setting by personnel trained in arthroscopy .
Published November 20, 2013 · Recall initiated: August 29, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Distributor
- 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.
- Lot
- All lots with a D identifier
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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