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.
Recall
- Recall Number
- Z-1121-2015
- Event Number
- 69782
- Firm
- Pulsion Medical Inc
- FEI Number
- 3010289715
- Product Code
- KRB
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- November 4, 2014
- Posted
- February 17, 2015
- Terminated
- October 2, 2015
- Address
- 3781 Attucks Dr, Powell, OH, 43065-6080
Description
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.
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
Pulsion sent an Urgent Medical Device Recall notification letter on 11/04/14 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers where instructed to: " Piease examine your inventory immediately to determine if you have any of the products listed. " lf so, please remove the affected products; quarantine them in a secure location. " Piease complete and return the enclosed Field Recall Response Form, acknowleding your receipt and understanding of this communication " Send all affected products back to PULSION Medical Systems. " Upon return of the affected product you will receive a credit note. For questions contact your PULSION Medical lnc Recall Coordinator.
US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
90 units