SleepNet Corporation recalls Phantom 2 Nasal Vented Mask

Recall date

March 1, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1357-2024

FDA classification

Class I

Brand / firm

SleepNet Corporation

Sold / distributed

Worldwide distribution - US Nationwide and the countries of AUSTRIA, BAHRAIN, BRAZIL, COLOMBIA, COSTA RICA, ECUADOR, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, INDIA, IRAQ, IRELAND, ISRAEL, ISREAL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NORWAY, POLAND,…

Why it was recalled

Update to contraindications and warning language due to CPAP masks containing magnets.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Phantom 2 Nasal Vented Mask