Device Recall DePuy Mitek FMS Intermediary Tubing with OneWay valve

  • Modèle / numéro de série
    All lots with a D identifier
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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 du dispositif
    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 || .
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    DePuy Mitek, Inc., a Johnson & Johnson Co., 325 Paramount Drive, Raynham MA 02767-5199
  • Société-mère du fabricant (2017)
  • Source
    USFDA