FDA-Device2015-02-25Class II
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.
Pulsion Medical Inc
Hazard
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
Sold states
US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
Affected count
90 units
Manufactured in
3781 Attucks Dr, Powell, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1121-2015Don't want to check this manually?
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