FDA Device recall Z-1121-2015
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package
- FDA Device
- Class II
- terminated
- Published 2015-02-25
On 2015-02-25 the FDA classified a Class II recall of Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package by Pulsion Medical, citing internal testing and investigation of the packaging revealed cracks and holes in primary packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1121-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-04 |
| Published | 2015-02-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Pulsion Medical |
| Distribution | US |
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
Identifiers
| code_info | Model Number PV8810US; Lot # 14AK20 and 14EK20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1121-2015%22
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