SleepNet Corporation Recall 94169
Description: Mojo 2 Full Face AAV Non Vented Mask, All Sizes
SleepNet Corporation Recall 94169 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1355-2024 |
| Event ID | 94169 |
| Event Description | Mojo 2 Full Face AAV Non Vented Mask, All Sizes |
| Product Type | Devices |
| 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, SWEDEN, SWITZERLAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VIETNAM, YEMEN. |
| Quantity | 1,268 units |
| Recall Reason | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Device Classification | 20240410 |
| Device Code Info | All UDI-DI; All Lot Numbers. |
| Center Classification Date | 20240401 |
| Recall Initiation Date | 20240301 |
| Recalling Firm | SleepNet Corporation |
| Initial Notification | Letter |
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