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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is regulatory (incorrect classification) rather than a direct physical safety defect with reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Pharmaceutical Innovations, Inc. is recalling Ultra/Phonic Focus BP Conforming Gel Pads. These gel pads are used on a woman's areola during an ultrasound examination to provide patient comfort over loose gel and assist with nipple location during the scan.
The recall was initiated because the firm registered the product as a Class I device, but the FDA has informed the firm that the device is not Class I and requires a 510(k) submission. The agency classification for this recall is Class II.
The affected lots were distributed nationwide in the United States, including in the state of Nevada. Consumers and healthcare providers should stop using the affected gel pads and contact the recalling firm for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Pharmaceutical Innovations, Inc.
- Hazard
Distribution
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