Recall Z-1121-2015 ยท KRB Probe, Thermodilution
Pulsion Medical Inc
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.
| Date | Feb 17, 2015 (initiated Nov 4, 2014) |
| Status | Terminated |
| Reason | Internal testing and investigation of the packaging revealed cracks and holes in primary packaging |
| Root cause | Packaging |
| Action | 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 re |
| Quantity | 90 units |
| Distribution | US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991886 | PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR Pulsion Medical Systems, Inc., May 11, 2000 |