Device Recall Outlook ES Safety Infusion System

  • Modèle / numéro de série
    Models 620-100 and 620-200; multiple serial numbers
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Disribution: USA (nationwide) and country of: Canada.
  • Description du dispositif
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, and 621-200ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    B Braun Medical, Inc., 1601 Wallace Dr Ste 150, Carrollton TX 75006-6690
  • Société-mère du fabricant (2017)
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AR, CA, FL, GA, IA, IL, KS, KY, LA, MA, MI, MO, NC, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and WV; and country of: Canada.
  • Description du dispositif
    Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES || B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 || The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required.
  • Manufacturer
  • Modèle / numéro de série
    Model number: 621-300ES and 621-400ES. Multiple serial numbers affected.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: AR, CA, FL, IL, LA, NC, NJ, NY, MD, ME, MN, SC, TN, TX, VA, WI, and WV.
  • Description du dispositif
    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
  • Manufacturer