Recall Z-2830-2020 — 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, makin
U.S. FDA — Device Enforcement · United States · 2020-08-13 · Class II
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Reported risk: 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.
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