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.
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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