Device Recall enFlow Disposable IV Fluid/Blood Warmer Cartridge

  • Model / Serial
    Model numbers: 9800200, 9800202, 9800200EU, 9800202EU, 9100020010, 9100020210, 91000153, 91000154, 91000156. Master lot numbers on shipping cartons: oo1K through 365K, 001P through 365P, 001S through 365S.  Shelf carton and unit level lot numbers" 0901xxxx through 1001xxxx
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution; USA (all states), and to the countries of Australia, Ecuador, Finland, India, Israel, Latvia, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Panama, Philippines, Qatar, Saudi Arabia, Singapore, Switzerland, the Netherlands, and Vietnam.
  • Product Description
    Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Vital Signs Inc, 20 Campus Rd, Totowa NJ 07512
  • Manufacturer Parent Company (2017)
  • Source
    USFDA