The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1121-2015·Announced 2015-02-25

Pulsiocath PiCCO ProAQT Monitoring Kit Recalled for Packaging Defects

Pulsion Medical Inc is recalling 90 units of the Pulsiocath PiCCO ProAQT Monitoring Kit due to cracks and holes found in the primary packaging.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves packaging defects without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Pulsion Medical Inc is recalling 90 units of the Pulsiocath PiCCO ProAQT Monitoring Kit. The affected products are single-use cardiac output sensors used to measure cardiac output by the thermodilution method, arterial blood pressure, and cardiac output determination by arterial pulse contour analysis. The recall is limited to Model Number PV8810US, Lot # 14AK20 and 14EK20.

The recall was initiated after internal testing and investigation revealed cracks and holes in the primary packaging of the devices. The affected product was distributed nationwide in the United States, specifically in the states of Connecticut, New Jersey, and New York, to one government consignee.

Consumers and healthcare facilities should stop using the affected units and contact Pulsion Medical Inc for further instructions on how to return or dispose of the product.

The recalled product

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…
Manufacturer
Pulsion Medical Inc
Category
Medical Device — Cardiac Monitoring
Hazard
Affected units
90

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model Number PV8810US
  • Lot # 14AK20 and 14EK20

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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