CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report
Fluid Management Convenience Kits recalled
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid. The recall was initiated on 18 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1390-2018
- FDA event ID
- 79558
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2018
- FDA classified
- 17 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 18 Jan 2018 | Recall initiated by company | |
| 17 Apr 2018 | Classified by FDA | +89 days |
| 25 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Where it was distributed
Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
Questions about this recall
Why was it 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 lots are affected?
Lot Numbers: 5284422 5286610 5283649 5290525 5286542
Where was it sold?
Recall conducted to end user level. Recall Notifications were delivered by Fed Express.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Angiodynamics Inc. (Navilyst Medical Inc.)
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Xcela PICC with Pasv Valve Technology/Kit 5 F recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Labeling Errors | NY |
| Device | CLASS II | Smart Port CT-Implantable Port recalled by Angiodynamics Inc. (Navilyst | Angiodynamics Inc. (Navilyst Medical Inc.) | Sterility | Nationwide |
| Device | CLASS II | AngioDynamics Safe Sheath Ultralite recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Sterility | Nationwide |
| Device | CLASS II | Starburst Talon Semi-Flex Electrosurgical Device recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Labeling Errors | 5 states |
| Device | CLASS II | Bioflo 8f Single Plastic Non-filled recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Device Malfunction | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |