Recall Z-1236-2017 ยท EGJ Device, Iontophoresis, Other Uses
Hidrex GmbH
Hidrex USA DP450
| Date | Feb 22, 2017 (initiated Jan 30, 2017) |
| Status | Terminated |
| Reason | The device was reclassified from a class III device to a class II device and there are new documentation requirements. |
| Root cause | Error in labeling |
| Action | Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed to be returned. |
| Quantity | 64 units |
| Distribution | Nationwide throughout the US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133033 | HIDREX PSP1000 Hidrex GmbH, Apr 8, 2015 |