FDA Device recall Z-1730-2025
MedicaLyte Liquid Bicarbonate Concentrate
- FDA Device
- Class I
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class I recall of MedicaLyte Liquid Bicarbonate Concentrate by Nipro Renal Soultions Usa, citing potential for the presence of visible foreign matter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1730-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-04-11 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Nipro Renal Soultions Usa |
| Distribution | US |
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).
Reason
Potential for the presence of visible foreign matter.
Identifiers
| code_info | a. Model Number: BC+201 (45X). Case UDI-DI: 10817411022821, Bottle UDI-DI: 00817411022824. All lot numbers. b. Model N…a. Model Number: BC+201 (45X). Case UDI-DI: 10817411022821, Bottle UDI-DI: 00817411022824. All lot numbers. b. Model Number: BC+100 36.83X. Case UDI-DI: 10817411022814, Bottle UDI-DI 00817411022817. Lot Numbers: N3C014, N3C018, N3F018, N4C010, N4C012, N4E004, N4L021, N4L022, N4L037, N5A044. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1730-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.