Recall Z-1357-2024— SleepNet Corporation

Name: FDA recall Z-1357-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-01

Class I · Ongoing

Class I FDA medical device recall by SleepNet Corporation, initiated 2024-03-01. It names one FDA 510(k) clearance: K211274. Product: Phantom 2 Nasal Vented Mask. Reason: Update to contraindications and warning language due to CPAP masks containing magnets..

Recalling firm: SleepNet Corporation
Classification: Class I
Status: Ongoing
Initiated: 2024-03-01
Firm location: Hampton, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K211274 — iQ 2 Nasal Mask, Phantom 2 Nasal MaskSleepnet Corporation·cleared 2022-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Phantom 2 Nasal Vented Mask

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.