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Angiodynamics Inc. (Navilyst Medical Inc.) recalls Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure M
Recalled April 25, 2018 · FDA recall Z-1390-2018 · Angiodynamics Inc. (Navilyst Medical Inc.)
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. · FDA Class II
Units
38 units
Sold at
Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
Description
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.
Product
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Manufacturer(s)
Angiodynamics Inc. (Navilyst Medical Inc.)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →