Mojo Non Vented Full Face Mask with Headgear, All Sizes
This recall is currently active, issued April 1, 2024. It was issued by Sleepnet Corporation.
- Company
- Sleepnet Corporation
- Recall Initiated
- March 1, 2024
- Posted
- April 1, 2024
- Recall Number
- Z-1352-2024
- Quantity
- 11,874 units
- Firm Location
- Hampton, NH
- Official Source
- View on FDA website ↗
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, SWEDEN, SWITZERLAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VIETNAM, YEMEN.
Lot / Code Info
All UDI-DI; All Lot Numbers.
Root Cause
Device Design
Action Taken
The firm emailed consignees a notification titled URGENT: MEDICAL DEVICE RECALL, dated 3/1/24. Consignees were instructed to stop using recalled masks if the user or anyone in close physical contact with the mask has an active medical implant or metallic implant that will interact with magnets and contact their mask provider for a replacement mask that does not contain magnets. Consignees that do not have an active medical implant or metallic implant that will interact with magnets do not have to cease use. If a consignee is unsure whether or not to cease use, they should consult with their physician or manufacturer of the implant. Consignees are to continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body. Consignees with any questions are to contact Himabindu Koppusetty via email at hkoppusetty@sleepnetcorp.com or by phone at 1-800-742-3646x6611 from Monday through from, 8:00 AM to 4:00 PM.