Drug recall
Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for…
FDA recall event 72484 · Class II · Fresenius Medical Care Renal Therapies Group, LLC
Key facts
| Event ID | 72484 |
|---|---|
| Recall numbers | Z-0294-2016, Z-0295-2016, Z-0296-2016 |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Product type | Devices |
| Products | Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the Preparation of acid concentrate for hemodialysis., Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis., Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075. For Use in the Preparation of acid concentrate for hemodialysis. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire. |
| Initiation date | Oct 23, 2015 |
| Report date | Nov 25, 2015 |
| Termination date | Mar 2, 2021 |
| 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: