FDA Recalls NovaStar TS Standard Elbow Reusable Components for Magnet Interference Risk
Draeger Medical is recalling 893 units of NovaStar TS Standard elbow components due to magnets that could interfere with 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 classification establishes a minimum severity of 4. The magnets could potentially interfere with implanted medical devices and metallic implants used in life-sustaining applications, even though no injuries have been reported.
Plain-English summary
Draeger Medical, Inc. is recalling 893 units of the NovaStar TS Standard elbow reusable respiratory component (Material Numbers MP01579 for Size S, MP01580 for Size M, and MP01581 for Size L). These units were distributed nationwide in the United States.
The magnets in the swivel frame/tube set and headgear clips may interfere with implanted medical devices, non-implanted medical devices, and metallic implants.
This recall affects patients with implanted medical devices or metallic implants who use or are fitted with this product.
The recalled product
- Product
- NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
- Manufacturer
- Draeger Medical, Inc.
- Hazard
- Affected units
- 893
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: 04048675040552 (MP01579)
- 04048675040569 (MP01580)
- 04048675040538 (MP01581)
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.
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