FDA Device recall Z-1390-2018
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems by Angiodynamics Navilyst Medical, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1390-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-18 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | n/a |
Product
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
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.
Identifiers
| code_info | Lot Numbers: 5284422 5286610 5283649 5290525 5286542 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2018%22
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