Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Reported: April 25, 2018 Initiated: January 18, 2018 #Z-1390-2018
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.
Details
- Recalling Firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Units Affected
- 38 units
- Distribution
- Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
- Location
- Glens Falls, NY
Frequently Asked Questions
What product was recalled? ▼
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.. Recalled by Angiodynamics Inc. (Navilyst Medical Inc.). Units affected: 38 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1390-2018.
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