Drug recall
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner…
FDA recall event 94881 · Class II · Medivance Inc.
Key facts
| Event ID | 94881 |
|---|---|
| Recall numbers | Z-2457-2024 |
| Recalling firm | Medivance Inc. |
| Product type | Devices |
| Products | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water… |
| Initiation date | Jun 27, 2024 |
| Report date | Aug 7, 2024 |
| City | Louisville |
| State | CO |
| Country | United States |
| FEI number | 3003329224 |
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: