Device recall
Z-3133-2026: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
FDA device recall · Class II · Nipro Renal Soultions USA, Corporation
Key facts
| Recall number (Z-number) | Z-3133-2026 |
|---|---|
| Recall event | 99573 |
| Product | MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 |
| Product code | KPO |
| Recalling firm | Nipro Renal Soultions USA, Corporation |
| Recall class | Class II |
| 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