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Recall Observatory FDA recall evidence

Device product

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

Z-1137-2023

January 23, 2023

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 91538
Status
Ongoing
Classification
Class I
Quantity
16 units
Official record key
device-enforcement:Z-1137-2023

Official wording

Reason: 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.

Code information: All Lot numbers. UDI-DI: 04048675041146 (MP10576); 04048675041153 (MP01577); 04048675041160 (MP01578)

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.