FDAClass IIFebruary 25, 2015

Pulsiocath PiCCO ProAQT Monitoring Kit recall

Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures…

Why was Pulsiocath PiCCO ProAQT Monitoring Kit recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number PV8810US; Lot # 14AK20 and 14EK20

Product
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures…
Recalling firm
Pulsion Medical Inc
Quantity
90 units
Distribution
US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
Recall date
February 25, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls