Drug recall
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating…
FDA recall event 73827 · Class II · C.R. Bard, Inc.
Key facts
| Event ID | 73827 |
|---|---|
| Recall numbers | Z-1617-2016 |
| Recalling firm | C.R. Bard, Inc. |
| Product type | Devices |
| Products | Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access… |
| Initiation date | Nov 9, 2015 |
| Report date | May 18, 2016 |
| Termination date | Jun 6, 2017 |
| City | Covington |
| State | GA |
| Country | United States |
| FEI number | 1018233 |
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: