FDA-Device2023-03-01Class I
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (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
893 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2023Don't want to check this manually?
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