Digital Pressure Monitor

Starting date:

October 21, 2016

Posting date:

November 15, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-61028

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  Reason
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  Affected products

Affected Products

Reason

A&D may have shipped blood pressure monitors that were not labeled for use with small cuff. The device is intended to be used with arm sizes from 5.1 inches to 17.7 inches or small cuffs (6.3-9.4") , medium cuffs ( 9.4-14.2"), and large cuffs (14.2-17.7"). For optimal comfort, the manufacturer adjusts the exhaust valve for the devices to be used with a small cuff. In doing so, the manufacturer may have not provided clear labeling on the front of these devices to indicate they have been adjusted for small cuff use. Additionally, some devices may have been labeled "adjusted for small cuffs" but may have been equipped with a medium cuff.

Affected products