FDA-Device2018-04-25Class II
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
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.
Sold states
Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
Affected count
38 units
Manufactured in
10 Glens Falls Tech Park, Glens Falls, NY, United States
Products
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2018Don't want to check this manually?
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