medical Class II Updated 2018-04-25

Angiodynamics Inc. (Navilyst Medical Inc.) recalls Fluid Management Convenience Kits (Angioplasty Kits) intende

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
Lot/Code Info: Lot Numbers: 5284422 5286610 5283649 5290525 5286542
View official government recall

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