Pulsion Medical Inc recalls Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable packag…

Recall date

November 4, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1121-2015

FDA classification

Class II

Brand / firm

Pulsion Medical Inc

Sold / distributed

US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.

Why it was recalled

Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.