Z-1352-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2024
- Initiation Date
- March 1, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,874 units
Product Description
Mojo Non Vented Full Face Mask with Headgear, All Sizes
Reason for Recall
Update to contraindications and warning language due to CPAP masks containing magnets.
Distribution Pattern
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.
Code Information
All UDI-DI; All Lot Numbers.