Home › Device types › FII
System, Dialysate Delivery, Sealed
FDA product code FII · Class 2 · Gastroenterology, Urology
0
Registered devices
3,214
Adverse events
2
Recalls
5
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-12-14 | Baxter Healthcare Renal Div | Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism. |
| 2004-02-20 | Baxter Healthcare Renal Div | These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire. |
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