Medical device recalls Moderate risk

Suntech Medical, Inc. recalls Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Ag…

Recall date
December 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0810-2020
FDA classification
Class II
Brand / firm
Suntech Medical, Inc.
Sold / distributed
No US Distribution; Internationally distributed to France, S. America

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).

Get recall alerts

Free email alert whenever Suntech Medical, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Suntech Medical, Inc.