Update to contraindications and warning language due to CPAP masks containing magnets.
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: 2477 units Lot/code info: All UDI-DI; All Lot Numbers.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.