Reported Feb 25, 2015 · Terminated
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable…
Pulsion Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pulsion Medical Inc · 3781 Attucks Dr · Powell, OH · 43065-6080
Is this the product you have?
- Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package
- Product UsageMeasures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis
- Lot codes and dates
Model Number PV8810USLot # 14AK20 and 14EK20
- Amount recalled
- 90 units
Where it was sold
Why it was recalled
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
This product could cause temporary or reversible health problems — stop using it.
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