Home / Recalls / Medical Devices
Pulsion Medical Inc recalls Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package
Recalled February 25, 2015 · FDA recall Z-1121-2015 · Pulsion Medical
Hazard
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging · FDA Class II
Units
90 units
Sold at
US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
Description
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
Product
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(s)
Pulsion Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →