FDA-Device2023-03-01Class I
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Draeger Medical, Inc.
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
16 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief