Recall Z-2854-2016 ยท KRA Catheter, Continuous Flush
EKOS Corporation
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
| Date | Aug 9, 2016 |
| Status | Terminated |
| Reason | The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device. |
| Root cause | Storage |
| Action | All affected consignees were contacted by e-mail on August 9, 2016, and asked to sequester implicated devices. |
| Quantity | 10 units |
| Distribution | Three international consignees - Germany, New Zealand and Taiwan |
| FDA record | Open on fda.gov |