Device Recall Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter

  • Modèle / numéro de série
    Lot Number: 0061583973
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : CA, IL, and TX., and Internationally to Canada.
  • Description du dispositif
    Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 || The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Société-mère du fabricant (2017)
  • Source
    USFDA