Model 250D Ambulatory Blood Pressure Monitor labeled recall
Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124…
Why was Model 250D Ambulatory Blood Pressure Monitor labeled recalled?
The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers.
- Product
- Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124…
- Recalling firm
- Suntech Medical, Inc.
- Quantity
- 384 units
- Distribution
- No US Distribution; Internationally distributed to France, S. America
- Recall date
- January 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)