PlainRecalls
FDA Devices Critical Class I Ongoing

NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)

Reported: March 1, 2023 Initiated: January 23, 2023 #Z-1137-2023

Product Description

NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)

Reason for Recall

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

Details

Recalling Firm
Draeger Medical, Inc.
Units Affected
16 units
Distribution
US Nationwide Distribution
Location
Telford, PA

Frequently Asked Questions

What product was recalled?
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L). Recalled by Draeger Medical, Inc.. Units affected: 16 units.
Why was this product recalled?
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 1, 2023. Severity: Critical. Recall number: Z-1137-2023.