Drug recall
Bicarby Dialysate; Model number: RFP-400-G;
FDA recall event 98892 · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Event ID | 98892 |
|---|---|
| Recall numbers | Z-2401-2026 |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Product type | Devices |
| Products | Bicarby Dialysate; Model number: RFP-400-G; |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the… |
| Initiation date | May 7, 2026 |
| Report date | Jun 17, 2026 |
| City | Waltham |
| State | MA |
| Country | United States |
| FEI number | 3001451489 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: