Sleepnet issues worldwide recall of CPAP and BIPAP masks

Photo source: FDA

The mask’s magnets may cause interference with certain medical implants

A worldwide recall has been issued by Sleepnet Corporation for all CPAP and BIPAP masks with magnets.

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.

The Sleepnet masks with magnets are safe when used in accordance with the newly updated Instructions for use.

There have been no medical device reports associated with the recalled masks.

The affected products include:

  • 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.

All lot/UDI numbers are included in the recall.

What to do

Do not use this mask if you or anyone -- household members, bed partners, caregivers, etc. -- in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets.

A patient, or anyone in close physical contact, with an active medical implant or metallic implant should contact their mask supplier to find a replacement mask that does not include magnets.

If the patient is unsure whether he/she should use the mask, the physician or the manufacturer of the implant should be consulted.

Consumers with questions may contact Sleepnet at (800) 742‐3646 from 8:00 AM – 4:00 PM (EST), or by email at hkoppusetty@sleepnetcorp.com.

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