iQ 2 Nasal Vented Mask Recalled for Magnet Safety Warnings
SleepNet Corporation is recalling the iQ 2 Nasal Vented Mask due to magnets requiring updated contraindication and warning language. Approximately 2,477 units distributed worldwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall classification requires a minimum severity score of 4 per the rubric. The recall addresses magnets in the device requiring updated contraindications and warnings, though no illnesses or injuries have been reported.
Plain-English summary
SleepNet Corporation is recalling the iQ 2 Nasal Vented Mask, a nasal CPAP device used for sleep apnea treatment. The recall affects approximately 2,477 units distributed nationwide in the United States and internationally to numerous countries.
The mask contains magnets that require updated contraindication and warning language to ensure safe use. The manufacturer is updating safety warnings to address potential hazards associated with the magnetic components.
The affected masks have been distributed worldwide, including throughout the United States and to numerous countries in Europe, Asia, the Middle East, and South America. Users of the iQ 2 Nasal Vented Mask should review the updated contraindication and warning information from the manufacturer and consult with their healthcare provider regarding safe use of this device.
The recalled product
- Product
- iQ 2 Nasal Vented Mask
- Manufacturer
- SleepNet Corporation
- Hazard
- Affected units
- 2,477
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All UDI-DI
- All Lot Numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by SleepNet Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · SleepNet Corporation
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