Pharmaceutical Innovations, Inc. recalls Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A ge…

Recall date

August 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2830-2020

FDA classification

Class II

Brand / firm

Pharmaceutical Innovations, Inc.

Sold / distributed

US Nationwide distribution including in the state of Nevada.

Why it was recalled

The firm registered the product as a Class I device, but has since been informed by FDA that the device is not Class I and requires a 510(k) submission.

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

What was recalled

Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.