Pharmaceutical Innovations Recalls Ultra/Phonic Focus BP Conforming Gel Pads
Pharmaceutical Innovations, Inc. is recalling Ultra/Phonic Focus BP Conforming Gel Pads because the device was incorrectly registered as a Class I device 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 du
- Category
- Medical Device
- Distribution
- Distributed nationwide