Device Recall Pulsiocath PiCCO ProAQT Monitoring Kit

  • Model / Serial
    Model Number PV8810US; Lot # 14AK20 and 14EK20
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
  • Product Description
    Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. || Product Usage: || Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Pulsion Medical Inc, 3781 Attucks Dr, Powell OH 43065-6080
  • Manufacturer Parent Company (2017)
  • Source
    USFDA