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Recall Observatory FDA recall evidence

Device product

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

Z-1390-2018

January 18, 2018

Class II

Product summary

Firm
Angiodynamics Inc. (Navilyst Medical Inc.)
Event
Event 79558
Status
Terminated
Classification
Class II
Quantity
38 units
Official record key
device-enforcement:Z-1390-2018

Official wording

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.

Code information: Lot Numbers: 5284422 5286610 5283649 5290525 5286542

Distribution pattern: Recall conducted to end user level. Recall Notifications were delivered by Fed Express.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.