Device Recall Level 1 Normothermic Administration Sets

  • Model / Serial
    Lot Numbers: 1974580 2007256 2064012 2089416 2093985
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution  (USA) (nationwide) - Argentina, Austria, Australia, Belgium, Bahrain, Bermuda, Canada, Chile, China, Columbia, Czech Republic, Germany, Denmark, Estonia, Egypt, Finland, France, Great Britain, Guernsey, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel India, Iceland, Italy, Japan, South Korea, Kazakhstan, Lebanon, Luxembourg, Mexico, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Panama, Poland, Portugal, Qatar, Singapore, Sweden, Slovak Republic, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, and Vatican City State.
  • Product Description
    Level 1¿ Normothermic I.V. Fluid Administration Sets, || Product Code D-60HL , || Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1¿¿ Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min - 530 ml/min.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Smiths Medical ASD, Inc., 160 Weymouth St, Rockland MA 02370-1136
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 2033447 2039136 2046398 2046400 2047961 2047963 2064528 2064529 2064530 2077404 2077405 2077406 2077407 2087667 2099050 2099766 2102361
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution  (USA) (nationwide) - Argentina, Austria, Australia, Belgium, Bahrain, Bermuda, Canada, Chile, China, Columbia, Czech Republic, Germany, Denmark, Estonia, Egypt, Finland, France, Great Britain, Guernsey, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel India, Iceland, Italy, Japan, South Korea, Kazakhstan, Lebanon, Luxembourg, Mexico, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Panama, Poland, Portugal, Qatar, Singapore, Sweden, Slovak Republic, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, and Vatican City State.
  • Product Description
    Level 1¿ Normothermic I.V. Fluid Administration Sets, || Product Code DI-60HL , || Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1¿¿ Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min - 530 ml/min.
  • Manufacturer