Angiodynamics Inc. (Navilyst Medical Inc.) recalls Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure M…

Recall date

January 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1390-2018

FDA classification

Class II

Brand / firm

Angiodynamics Inc. (Navilyst Medical Inc.)

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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