Drug recall
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a…
FDA recall event 87894 · Class II · Medivators, Inc.
Key facts
| Event ID | 87894 |
|---|---|
| Recall numbers | Z-1859-2021 |
| Recalling firm | Medivators, Inc. |
| Product type | Devices |
| Products | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. |
| Initiation date | Apr 20, 2021 |
| Report date | Jun 23, 2021 |
| Termination date | Jul 11, 2024 |
| City | Plymouth |
| State | MN |
| Country | United States |
| FEI number | 2150060 |
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: