The Recall Desk
SevereFDA (Devices)·Z-1137-2023·Announced 2023-03-01

NovaStar TS Anti-Asphyxia Valve recalled for magnetic interference risk

Draeger Medical recalls NovaStar TS Anti-Asphyxia Valves due to magnets that may interfere with implanted and non-implanted medical devices and metallic implants.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which requires a minimum Severe (4) rating per the severity rubric. Although no illnesses or injuries have been reported, the potential for magnetic interference with critical medical devices and implants justifies this classification.

Plain-English summary

Draeger Medical, Inc. is recalling the NovaStar TS Anti-Asphyxia Valve (Reusable) in all three sizes (S, M, L) nationwide. The recall concerns magnets in the swivel frame/tube set and headgear clips that may impact both implanted and non-implanted medical devices, as well as metallic implants.

This recall affects individuals using the NovaStar TS Anti-Asphyxia Valve who have implanted or non-implanted medical devices or metallic implants. Anyone in this category should discontinue use and contact their healthcare provider immediately.

Consumers should stop using the affected valve right away if they have any implanted medical devices or metallic implants. Patients should speak with their healthcare provider for guidance on safe respiratory protection alternatives during the recall.

The recalled product

Product
NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (Size L)
Manufacturer
Draeger Medical, Inc.
Hazard
  • magnetic-interference

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.