Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category: Medical Device — Respiratory Protection Equipment
Hazard: magnetic-interference
Affected units: 16

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.

Part of a larger recall action

This product is one of 2 recalled by Draeger Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Draeger Medical, Inc.

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Same hazard · magnetic interference