Drug recall
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70…
FDA recall event 75557 · Class III · Smiths Medical ASD, Inc.
Key facts
| Event ID | 75557 |
|---|---|
| Recall numbers | Z-1145-2017 |
| Recalling firm | Smiths Medical ASD, Inc. |
| Product type | Devices |
| Products | HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | HOTLINE Blood and Fluid Warmers included Greek and Danish language labeling instead of the required Finnish labeling. |
| Initiation date | Oct 31, 2016 |
| Report date | Feb 15, 2017 |
| Termination date | Nov 27, 2017 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2183502 |
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: