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Pharmaceutical Innovations, Inc. recalls Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel
Recalled August 26, 2020 · FDA recall Z-2830-2020 · Pharmaceutical Innovations
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. · FDA Class II
Units
tbd
Sold at
US Nationwide distribution including in the state of Nevada.
Description
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.
Product
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.
Manufacturer(s)
Pharmaceutical Innovations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →