Recall Z-1390-2018 ยท OEQ Angiography/Angioplasty Kit
Angiodynamics Inc. (Navilyst Medical Inc.)
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
| Date | Jan 18, 2018 |
| Status | Terminated |
| Reason | NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure. |
| Root cause | Under Investigation by firm |
| Action | Recall Notifications were delivered by Fed Express. Consignees instructed to segregate and return all affected devices to Angiodynamics and complete and return the Reply Verification Tracking Form. |
| Quantity | 38 units |
| Distribution | Recall conducted to end user level. Recall Notifications were delivered by Fed Express. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.