Mojo 2 Full Face AAV Non Vented Mask, All Sizes

FDA device recall Z-1355-2024 · posted 2024-04-01 · Open, Classified

Recall details

Recalling firm

SleepNet Corporation

Reason for recall

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

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.

Root cause

Device Design

Status

Open, Classified

Product code

BZD

Quantity affected

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,

Date initiated

2024-03-01

Date posted

2024-04-01

Location

Hampton, NH

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