Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2018 - (Recall #: Z-1390-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.

Product Classification:

Class II

Date Initiated: January 18, 2018

Date Posted: April 25, 2018

Recall Number: Z-1390-2018

Event ID: 79558

Reason for Recall:

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.

Status: Terminated

Product Quantity: 38 units

Code Information:

Lot Numbers: 5284422 5286610 5283649 5290525 5286542

Distribution Pattern:

Recall conducted to end user level. Recall Notifications were delivered by Fed Express.

Voluntary or Mandated:

Voluntary: Firm initiated