Recall Z-2189-2013 ยท DRS Transducer, Blood-Pressure, Extravascular
Edwards Lifesciences, LLC
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
| Date | Sep 11, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration. |
| Root cause | Packaging process control |
| Action | Edwards Lifesciences initiated a US recall via an Urgent Product Recall letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that an Edweards Lifesciences representative would come to their facility to retrieve the affected device. A device replacement would be provided to the customer. Customers were asked to complete the enclosed Confirmation Form and give it to the Edwards Lifesciences representative that will come to their facility. For customers with questions were in |
| Quantity | 35 units |
| Distribution | Nationwide Distribution including MO and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043065 | VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P Edwards Lifesciences, LLC, Jan 26, 2005 |