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.

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.

On 8/13/2020, the firm distributed Urgent Medical Device Recall letters to its distributor, with instructions to notify all affected customers who received the product. Customers were informed that the product had been misclassified by the firm and required a 510(k) submission to FDA. Customers were instructed to identify and quarantine the products, and to cease use and sales of the product. Customers are to complete the included response form and return it to the firm. The firm will issue a Return Material Authorization for the return of the product. No option will be given to destroy product in the field. Customers should notify all users within their facility as well as any downstream accounts if the product has been further distributed/ transferred.