NAMIC Fluid Management Convenience Kits Recalled for Assembly Defect
Angiodynamics Inc. is recalling 38 NAMIC Fluid Management Convenience Kits because the Fluid Delivery Set was not assembled to specification, preventing device use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The defect prevents device use, causing a minor delay in procedure, which aligns with the rubric for moderate severity involving functional issues without reported injury.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 38 units of NAMIC Fluid Management Convenience Kits (Angioplasty Kits). These kits are intended for use in Fluid Management and/or Invasive Pressure Monitoring systems.
The recall was initiated because the Fluid Delivery Set contained in the kits was not assembled in accordance with specification. This defect prevents the device from being used, which results in a minor delay in the procedure.
The recall is being conducted to the end-user level, with notifications delivered by FedEx. The affected lot numbers are 5284422, 5286610, 5283649, 5290525, and 5286542. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 5284422 5286610 5283649 5290525 5286542
Distribution
Distribution scope not specified by the agency.
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