FDA Device

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

Hazard

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.

What You Should Do

Remedy

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.

Products

Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Brand
Angiodynamics Inc. (Navilyst Medical Inc.)
UPC
Lot Numbers: 5284422 5286610 5283649 5290525 5286542

Units Affected

38 units