FDA Device Recall Z-1356-2024

SleepNet Corporation · Hampton, NH

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

iQ 2 Nasal Vented Mask

Lot / serial / GTIN: All UDI-DI; All Lot Numbers.

Quantity: 2477 units

Reason for recall

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

Recall record

Recall number: Z-1356-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
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.
Recall initiated: 2024-03-01
Classified by FDA Center: 2024-04-01
FDA published: 2024-04-10
Recalling firm: SleepNet Corporation
Firm location: Hampton, NH

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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