Fluid Management Convenience Kits recall
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Why was Fluid Management Convenience Kits 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 5284422 5286610 5283649 5290525 5286542
- Product
- Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Quantity
- 38 units
- Distribution
- Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
- Recall date
- April 25, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)