FDA Recall
Terminated
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.
Recall: Z-0063-2017
·
Initiated September 12, 2016
Recall
- Recall Number
- Z-0063-2017
- Event Number
- 75177
- Firm
- A & D Enginering Inc
- FEI Number
- 2082313
- Product Code
- DXN
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- September 12, 2016
- Terminated
- August 28, 2018
- Address
- 1756 Automation Pkwy, San Jose, CA, 95131-1873
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
A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.
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.
Distribution
to distributors in NY, MA, VA. TX,
Quantity
378 units