Z-1390-2018 Class II Terminated
FDA device recall Z-1390-2018 was initiated by Angiodynamics Inc. (Navilyst Medical Inc.) on Jan 18, 2018 and is designated Class II. 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… The recall status is terminated (terminated Sep 21, 2018). Affected quantity: 38 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 25, 2018
- Initiation Date
- Jan 18, 2018
- Termination Date
- Sep 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 units
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.
Distribution Pattern
Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
Code Information
Lot Numbers: 5284422 5286610 5283649 5290525 5286542
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1390-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026