Recall Z-0063-2017 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
A & D Enginering Inc
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.
| Date | Sep 12, 2016 |
| Status | Terminated |
| Reason | A&D may have shipped blood pressure monitors that were not labeled for use with small cuff. |
| Root cause | Labeling Change Control |
| 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. |
| Quantity | 378 units |
| Distribution | to distributors in NY, MA, VA. TX, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR A&D Engineering, Inc., Mar 3, 2005 |