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www.fdanews.com/articles/213419-sleepnet-cpap-and-bipap-mask-magnets-force-recall

Sleepnet CPAP and BIPAP Mask Magnets Force Recall

March 21, 2024

Magnets in Sleepnet’s CPAP and BIPAP masks can potentially interfere with nearby medical devices or metallic implants, causing the company to initiate a voluntary worldwide company recall.

When a magnet in the product comes in close proximity with certain medical or metallic implants, there is a potential for serious injury or death, according to New Hampshire-based Sleepnet. The company, having distributed masks with magnets since 2006, says there have been no Medical Device Reports associated with the masks.

A new contraindication and updated warning are being added to the affected products’ labeling, to also be included in labeling for all future mask production.

View the affected products and warning in the Sleepnet news release here.

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