The U.S. Food and Drug Administration says Sleepnet Corporation has initiated a 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 worldwide since 2006 and to date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets. This is a voluntary action based on information obtained from post market surveillance.
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. Two examples of the products recalled accompanies this story.
If a patient or anyone, such as household members, bed partners, caregivers, etc., in close physical contact with the mask has an active medical implant or metallic implant that will interact with magnets, these masks with magnets should not be used.
Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic metallic implants/electrodes/valves placed in upper limbs , torso, or higher, etc.
If you have any questions regarding the implant, consult your physician or the manufacturer of your implant.
Consumers may also call 1-800-742‐3646 between the hours of 8:00 a.m. to 4:00 p.m.
By Tom Latek, Kentucky Today
