FDA-Device2024-04-10Class I
Mojo 2 Full Face Vented Mask, All Sizes
SleepNet Corporation
Hazard
Update to contraindications and warning language due to CPAP masks containing magnets.
Sold states
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, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SULTANATE OF OMAN, SWEDEN, SWITZERLAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VIETNAM, YEMEN.
Affected count
2,787 units
Manufactured in
5 Merrill Industrial Dr, Hampton, NH, United States
Products
Mojo 2 Full Face Vented Mask, All Sizes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1353-2024Don't want to check this manually?
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