FDA Enforcement
Class I
Ongoing
Phantom 2 Nasal Vented Mask
Recall: Z-1357-2024
·
Reported April 10, 2024
Enforcement
- Recall Number
- Z-1357-2024
- Event ID
- 94169
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SleepNet Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 10, 2024
- Initiation Date
- March 1, 2024
- Classification Date
- April 1, 2024
- Address
- 5 Merrill Industrial Dr, Hampton, NH, 03842-1980, United States
Description
Phantom 2 Nasal Vented Mask
Reason
Update to contraindications and warning language due to CPAP masks containing magnets.
Code Info
All UDI-DI; All Lot Numbers.
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.
Quantity
2417 units