BMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
BMC Medical is recalling 20,160 Luna G3 APAP devices to report 2024 rework conducted at a warehouse.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as unlikely to cause adverse health consequences. The source text describes a retroactive reporting issue for rework without mentioning any reported injuries, illnesses, or specific safety hazards.
Plain-English summary
BMC Medical Co., Ltd. is recalling 20,160 units of the BMC/REACTHEALTH Luna G3 APAP (REF LG 3600) medical device. The recall is initiated for retroactive reporting of rework that was conducted in 2024 at the 3B/React Health warehouse.
The affected devices are identified by UDI 06948538363331 and 06948538365892, with software version G3-2.00.76. The source text does not specify the specific nature of the rework or the potential safety hazards associated with it. The distribution pattern is listed as US distribution to FL, with no other US states specified.
Consumers and healthcare providers should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. The source text does not provide specific consumer instructions or contact information for the recall.
The recalled product
- Product
- BMC/REACTHEALTH Luna G3 APAP REF LG 3600
- Manufacturer
- BMC Medical Co., Ltd.
- Hazard
- Affected units
- 20,160
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 (1)
- UDI: 06948538363331
Distribution
Distributed in 1 state:
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