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Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, par...

FDA Recall #Z-0810-2020 — Class II — December 11, 2019

Recall #Z-0810-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

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).

Reason for Recall

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.

Recalling Firm

Suntech Medical, Inc. — Morrisville, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

384 units

Distribution

No US Distribution; Internationally distributed to France, S. America

Code Information

All serial numbers.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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