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Open, Classified

Mojo 2 Full Face Non Vented Mask, All Sizes

FDA Recall Z-1354-2024 · Posted 2024-04-01

Recalling FirmSleepNet Corporation
Recall StatusOpen, Classified
Product CodeBZD
Date Initiated2024-03-01
Product Quantity2,107 units

Reason for Recall

Update to contraindications and warning language due to CPAP masks containing magnets.

Firm 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 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 [email protected] or by phone at 1-800-742-3646x6611 from Monday through from, 8:00 AM to 4:00 PM.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-VentedSleepnet Corporation · 2019-07-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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