Drug recall
iQ 2 Nasal Vented Mask
FDA recall event 94169 · Class I · SleepNet Corporation
Key facts
| Event ID | 94169 |
|---|---|
| Recall numbers | Z-1351-2024, Z-1352-2024, Z-1353-2024, Z-1354-2024, Z-1355-2024, Z-1356-2024, Z-1357-2024 |
| Recalling firm | SleepNet Corporation |
| Product type | Devices |
| Products | iQ 2 Nasal Vented Mask, Mojo 2 Full Face AAV Non Vented Mask, All Sizes, Mojo 2 Full Face Non Vented Mask, All Sizes, Mojo 2 Full Face Vented Mask, All Sizes, Mojo Full Face with Headgear, All Sizes and 2 more |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Initiation date | Mar 1, 2024 |
| Report date | Apr 10, 2024 |
| City | Hampton |
| State | NH |
| Country | United States |
| FEI number | 1222088 |
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: