Recall Z-0810-2020— Suntech Medical, Inc.

Name: FDA recall Z-0810-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-11

Class II · Terminated

Class II FDA medical device recall by Suntech Medical, Inc., initiated 2019-12-11, terminated 2023-04-10. It names one FDA 510(k) clearance: K151520. 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).. Reason: 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.
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Terminated: 2023-04-10
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K151520 — Oscar 2Suntech Medical, Inc.·cleared 2016-02-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.