AirFit F30i Full Face Mask Recalled Due to Magnetic Interference Risk
ResMed is recalling the AirFit F30i Full Face Mask due to potential magnetic interference with active medical implants and ferromagnetic objects. Safety warnings are being updated.
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: This is an FDA Class I recall, which establishes a minimum severity score of 4. The potential for magnetic interference with implanted medical devices poses a serious risk of harm, though no illnesses or injuries are currently reported.
Plain-English summary
ResMed Ltd. is recalling the AirFit F30i Full Face Mask and User Guide to address potential magnetic interference with patients' active medical implants and ferromagnetic implants or objects.
The masks contain magnets that can interfere with active medical implants that interact with magnets, as well as with metallic implants or objects containing ferromagnetic material. The company is updating contraindications and warnings regarding safe distance between the mask and medical devices or implants.
Approximately 2,037,323 units have been distributed nationwide in the United States, including Puerto Rico, Guam, and the Virgin Islands, as well as internationally to numerous countries. Patients using the AirFit F30i Full Face Mask, particularly those with implanted medical devices, should review the updated safety information and consult with their healthcare provider about safe use.
The recalled product
- Product
- AirFit F30i Full Face Mask and User Guide
- Manufacturer
- ResMed Ltd.
- Category
- Medical Device — Full Face Mask
- Hazard
- magnetic-interference
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 (20)
- All mask lots used with User Guide 638225/version 2020-02
- and prior. UDI-DI/GTIN: 619498633326
- 619498633067
- 619498633012
- 619498633340
- 619498633302
- 619498633333
- 619498633050
- 619498633319
- 619498633005
- 619498633135
- 619498633128
- 619498633364
- 619498633388
- 619498633371
- 619498633401
- 619498633395
- 619498633104
- 619498633142
- 619498633111
Distribution
Distributed nationwide across the United States.
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