Sleepnet Corp initiated a worldwide recall for all CPAP and BiPAP masks with magnets attributable to potential interference with sure medical gadgets, in accordance with an FDA recall alert.
In response to the FDA, when a magnet comes into shut proximity to sure medical implants or metallic implants, it may intervene with the efficiency or the place of the implant, doubtlessly leading to severe damage or demise.
Sleepnet has been distributing masks with magnets worldwide since 2006 and up to now, there have been no Medical Machine Reviews related to the Sleepnet masks with magnets. This can be a voluntary motion based mostly on info obtained from put up market surveillance, the FDA says.
Affected merchandise embrace:
- Mojo Full Face Vented Masks
- Mojo Full Face Non‐Vented Masks
- Mojo 2 Full Face Vented Masks
- Mojo 2 Full Face Non‐Vented Masks,
- Mojo 2 Full Face AAV Non‐Vented Masks,
- iQ 2 Nasal Masks, and
- Phantom 2 Nasal Masks.
- That is relevant to all lot/UDI numbers.
If a affected person or anybody (instance: family members, mattress companions, caregivers, and many others.) in shut bodily contact with the masks has an energetic medical implant or metallic implant that may work together with magnets, these masks with magnets shouldn’t be used.
Implant examples embrace, however usually are not restricted 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 revive listening to or steadiness with implanted magnets (similar to cochlear implants), move disruption gadgets, contact lenses with metallic, dental implants, metallic cranial plates, screws, burr gap covers, bone substitute system, magnetic metallic implants/electrodes/valves positioned in higher limbs , torso, or greater, and many others.
Sleepnet masks with magnets are protected when utilized in accordance with the newly up to date Directions for Use. Proceed utilizing masks in accordance with the up to date directions and labeling if sufferers or individuals in shut proximity to them should not have implanted metallic medical gadgets or metallic objects within the physique.
Sleepnet is including a brand new contraindication and an up to date warning to the Directions for Use labeling of the affected merchandise. This can be included within the labeling for all future manufacturing of those masks. The labeling can be up to date to state the next:
New Contraindication
Don’t use this masks in case you or anybody (instance: family members, mattress companions, caregivers, and many others.) in shut bodily contact together with your masks has an energetic medical implant or metallic implant that may work together with magnets. Implant examples embrace, however usually are not restricted 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 revive listening to or steadiness with implanted magnets (similar to cochlear implants), move disruption gadgets, contact lenses with metallic, dental implants, metallic cranial plates, screws, burr gap covers, bone substitute system, magnetic metallic implants/electrodes/valves positioned in higher limbs , torso, or greater, and many others. When you’ve got any questions relating to the implant, seek the advice of your doctor or the producer of your implant.
Up to date Warning
Magnets are used within the masks and headgear clips with a area power of 380mT. Apart from the gadgets recognized within the contraindication, be sure that the masks is saved not less than 6 inches (approx. 16 cm) away from another medical implants or medical gadgets that may be impacted by the magnetic fields to keep away from attainable results from localized magnetic fields. This is applicable to you or anybody in shut bodily contact together with your masks.
If a affected person, or anybody in shut bodily contact, has an energetic medical implant or metallic implant, they need to contact their masks provider to discover a alternative masks that doesn’t embrace magnets. If the affected person is uncertain whether or not or not they need to use the masks, they need to seek the advice of their doctor or the producer of their implant.
sleepnet masks recall
