Pulsion Medical Inc: Medical Device Recall in 2015 - (Recall #: Z-1121-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 4, 2014

Date Posted: February 25, 2015

Recall Number: Z-1121-2015

Event ID: 69782

Reason for Recall:

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

Status: Terminated

Product Quantity: 90 units

Code Information:

Model Number PV8810US; Lot # 14AK20 and 14EK20

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated