Z-1121-2015 Class II Terminated
FDA device recall Z-1121-2015 was initiated by Pulsion Medical Inc on November 4, 2014 and is designated Class II. Reason for recall: Internal testing and investigation of the packaging revealed cracks and holes in primary packaging The recall status is terminated (terminated October 2, 2015). Affected quantity: 90 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2015
- Initiation Date
- November 4, 2014
- Termination Date
- October 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 units
Product 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.
Reason for Recall
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
Distribution Pattern
US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
Code Information
Model Number PV8810US; Lot # 14AK20 and 14EK20