Recall Z-2830-2020— Pharmaceutical Innovations, Inc.
Class II · Terminated
Class II FDA medical device recall by Pharmaceutical Innovations, Inc., initiated 2020-08-13, terminated 2021-09-16. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Pharmaceutical Innovations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-13
- Terminated
- 2021-09-16
- Firm location
- Newark, NJ, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.