Device Recall Prometra II Programmable Infusion Pump

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. || The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Flowonix Medical, Inc., 500 International Dr Ste 200, Mount Olive NJ 07828-1381
  • Société-mère du fabricant (2017)
  • Source