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.
FDA Recall Z-0063-2017 · Posted None
Advertisement
Recalling FirmA & D Enginering Inc
Recall StatusTerminated
Product CodeDXN
Date Initiated2016-09-12
Date Terminated2018-08-28
Product Quantity378 units
Reason for Recall
A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.
Firm Action
Notification letters were sent on September 12, 2016 to all affected customers. Letters identify the product and reason for the recall. Letters include a serial number list that is customer specific and ask that inventory be reviewed and that other organizations that may be impacted by this issue be notified.
Root Cause
Labeling Change Control
Distribution Pattern
to distributors in NY, MA, VA. TX,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement