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U.S. Department of Health and Human Services

Class 1 Device Recall Mojo Full Face with Headgear

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  Class 1 Device Recall Mojo Full Face with Headgear see related information
Date Initiated by Firm March 01, 2024
Date Posted April 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-1351-2024
Recall Event ID 94169
510(K)Number K120463  
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
Product Mojo Full Face with Headgear, All Sizes
Code Information All UDI-DI; All Lot Numbers.
Recalling Firm/
Manufacturer		 SleepNet Corporation
5 Merrill Industrial Dr
Hampton NH 03842-1980
For Additional Information Contact Himabindu Koppusetty
603-758-6611
Manufacturer Reason
for Recall		 Update to contraindications and warning language due to CPAP masks containing magnets.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 23,042 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, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BZD and Original Applicant = SLEEPNET CORPORATION
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