Pulsiocath PiCCO ProAQT Monitoring Kit — Class II medical device recall Z-1121-2015
Terminated recall by Pulsion Medical Inc, reported 2015-02-25, distributed nationwide. Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
| Recall number | Z-1121-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pulsion Medical Inc, Powell, OH, United States |
| Recall initiated | 2014-11-04 |
| Classified | 2015-02-17 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2015-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 90 units |
| Reason classes | packaging |
| Lot numbers | 14AK20, 14EK20 |
| Model numbers | PV8810US |
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 for recall
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1121-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.