Drug recall
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
FDA recall event 78327 · Class II · 3M Company - Health Care Business
Key facts
| Event ID | 78327 |
|---|---|
| Recall numbers | Z-0114-2018 |
| Recalling firm | 3M Company - Health Care Business |
| Product type | Devices |
| Products | 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patient s… |
| Initiation date | Oct 17, 2017 |
| Report date | Nov 29, 2017 |
| Termination date | Nov 3, 2020 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2110898 |
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: