SleepNet Corporation: Mojo Non Vented Full Face Mask with Headgear, All Sizes

Hazard

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

Details from the source

Reason for recall: Update to contraindications and warning language due to CPAP masks containing magnets. Distribution: 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, Quantity: 11,874 units Lot/code info: All UDI-DI; All Lot Numbers.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.