Recall Z-0063-2017— A & D Enginering Inc

Name: FDA recall Z-0063-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-12

Class II · Terminated

Class II FDA medical device recall by A & D Enginering Inc, initiated 2016-09-12, terminated 2018-08-28. It names one FDA 510(k) clearance: K043217. Product: Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate.. Reason: A&D may have shipped blood pressure monitors that were not labeled for use with small cuff..

Recalling firm: A & D Enginering Inc
Classification: Class II
Status: Terminated
Initiated: 2016-09-12
Terminated: 2018-08-28
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K043217 — A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITORA&D Engineering, Inc.·cleared 2005-03-03

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

Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate.

Reason for recall

A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.

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