Device recall
Z-1730-2025: MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100…
FDA device recall · Class I · Nipro Renal Soultions USA, Corporation
Key facts
| Recall number (Z-number) | Z-1730-2025 |
|---|---|
| Recall event | 96646 |
| Product | MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case). |
| Product code | KPO |
| Recalling firm | Nipro Renal Soultions USA, Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K012547 |
| FEI number | 1000142899 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database