Recall Z-1390-2018— Angiodynamics Inc. (Navilyst Medical Inc.)
Class II · Terminated
Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2018-01-18, terminated 2018-09-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.. Reason: 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..
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-18
- Terminated
- 2018-09-21
- Firm location
- Glens Falls, NY, United States
Product description
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.