Recall Z-1355-2024 ยท BZD Ventilator, Non-Continuous (Respirator)
SleepNet Corporation
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
| Date | Apr 1, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| Reason | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Root cause | Device Design |
| Action | 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 ph |
| Quantity | 1,268 units |
| 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, Q |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Sleepnet Corporation, Jul 26, 2019 |