Recall Z-1121-2015— Pulsion Medical Inc

Name: FDA recall Z-1121-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-04

Class II · Terminated

Class II FDA medical device recall by Pulsion Medical Inc, initiated 2014-11-04, terminated 2015-10-02. It names one FDA 510(k) clearance: K991886. 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.. Reason: Internal testing and investigation of the packaging revealed cracks and holes in primary packaging.

Recalling firm: Pulsion Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Terminated: 2015-10-02
Firm location: Powell, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSORPulsion Medical Systems, Inc.·cleared 2000-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.