Drug recall
8500M Handheld Pulse Oximeter
FDA recall event 75424 · Class II · Nonin Medical, Inc
Key facts
| Event ID | 75424 |
|---|---|
| Recall numbers | Z-1690-2017 |
| Recalling firm | Nonin Medical, Inc |
| Product type | Devices |
| Products | 8500M Handheld Pulse Oximeter |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct… |
| Initiation date | Sep 29, 2016 |
| Report date | Apr 5, 2017 |
| Termination date | Mar 12, 2018 |
| City | Plymouth |
| State | MN |
| Country | United States |
| FEI number | 2183646 |
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: