Suntech Medical Recalls Model 250D Ambulatory Blood Pressure Monitors for Battery Safety
Suntech Medical is recalling 384 Model 250D Ambulatory Blood Pressure Monitors due to a user safety issue involving the misuse of rechargeable batteries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source text identifies a user safety issue but does not report any specific injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Suntech Medical, Inc. is recalling 384 units of the Model 250D Ambulatory Blood Pressure Monitor. The devices are sold under the brands Bravo Mini, Agilis Mini, and NBP One. The recall is being conducted by the U.S. Food and Drug Administration (FDA) as a Class II recall.
The recall is due to a user safety issue that occurs when rechargeable batteries are misused in the product. The source text does not specify the exact nature of the safety hazard or the potential consequences of the battery misuse.
The affected devices were distributed internationally to France and South America. There is no US distribution of these units. The source text does not provide specific instructions for consumers on how to respond to the recall, nor does it report any illnesses or injuries associated with the product.
The recalled product
- Product
- Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).
- Manufacturer
- Suntech Medical, Inc.
- Hazard
- Affected units
- 384
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)
- All serial numbers.
Distribution
Distribution scope not specified by the agency.
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