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FDAAugust 13, 2020device

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, ma...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

pharmaceutical innovationspharmaceutical

UPCs

0030036130102110300361301028

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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