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.
Reported: August 26, 2020 Initiated: August 13, 2020 #Z-2830-2020
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.
Details
- Recalling Firm
- Pharmaceutical Innovations, Inc.
- Units Affected
- tbd
- Distribution
- US Nationwide distribution including in the state of Nevada.
- Location
- Newark, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pharmaceutical Innovations, Inc.. Units affected: tbd.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2020. Severity: Moderate. Recall number: Z-2830-2020.
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