Medical device recalls Moderate risk

A & D Enginering Inc recalls Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and ol…

Recall date
September 12, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0063-2017
FDA classification
Class II
Brand / firm
A & D Enginering Inc
Sold / distributed
to distributors in NY, MA, VA. TX,

Why it was recalled

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

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

What was recalled

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.

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