🔍 RecallPedia

Pharmaceutical Innovations

6 recalls •
🏥 Medical Devices
• Categories: Other Medical Devices, Infusion Pumps

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 I - Dangerous

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.

Aug 13, 2020 Other Medical Devices Nationwide View Details →