Drug recall
Level 1 Fluid Warmer, Model H-1000, H-500, H-1025
FDA recall event 88445 · Class I · Smiths Medical ASD Inc.
Key facts
| Event ID | 88445 |
|---|---|
| Recall numbers | B-0568-2021, B-0569-2021, B-0570-2021 |
| Recalling firm | Smiths Medical ASD Inc. |
| Product type | Biologics |
| Products | Level 1 Fluid Warmer, Model H-1000, H-500, H-1025, Level 1 Fluid Warming System , Model H-1028, H-1200, Level 1 Normothermic I.V. Fluid Administration Set , Model D-100, D-300, D-50, D-60HL, D-70, DI-100, DI-300, DI-50, DI-60HL, DI-70 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Fast Flow Fluid Warming and Irrigation System Disposables, contain aluminum heat exchangers which have the potential to leach high levels of aluminum during the infusion of blood products, were… |
| Initiation date | Aug 17, 2021 |
| Report date | Sep 15, 2021 |
| Termination date | Aug 7, 2024 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3012307300 |
At a glance
- 1–9 Products in this recall
- 1–9 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: