iQ 2 Nasal Vented Mask
Reported: April 10, 2024 Initiated: March 1, 2024 #Z-1356-2024
Product Description
iQ 2 Nasal Vented Mask
Reason for Recall
Update to contraindications and warning language due to CPAP masks containing magnets.
Details
- Recalling Firm
- SleepNet Corporation
- Units Affected
- 2477 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.
- Location
- Hampton, NH
Frequently Asked Questions
What product was recalled? ▼
iQ 2 Nasal Vented Mask. Recalled by SleepNet Corporation. Units affected: 2477 units.
Why was this product recalled? ▼
Update to contraindications and warning language due to CPAP masks containing magnets.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2024. Severity: Critical. Recall number: Z-1356-2024.
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