Sleepnet recalls masks with magnets
By HME News Staff
Updated 10:14 AM CDT, Thu March 21, 2024
HAMPTON, N.H. – Sleepnet Corporation has initiated a voluntary worldwide recall for all CPAP and BiPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or the position of the implant, potentially resulting in serious injury or death. Sleepnet has been distributing masks with magnets since 2006 and to date there have been no Medical Device Reports associated with the Sleepnet masks with magnets. Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This is applicable to all lot/UDI numbers. Sleepnet says its masks with magnets are safe when used in accordance with the newly updated instructions for use. It says users can continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body. Sleepnet is adding a new contraindication and an updated warning to the Instructions for Use labeling of the affected products. This will be included in the labeling for all future production of these masks. Consumers with questions may contact Sleepnet at hkoppusetty@sleepnetcorp.com or call 1‐800‐742‐3646.
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