Pharmaceutical Innovations, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2830-2020)

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.

Class II

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.

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US Nationwide distribution including in the state of Nevada.

Voluntary: Firm initiated