Drug recall
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product…
FDA recall event 86138 · Class II · Pharmaceutical Innovations, Inc.
Key facts
| Event ID | 86138 |
|---|---|
| Recall numbers | Z-2830-2020 |
| Recalling firm | Pharmaceutical Innovations, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Aug 13, 2020 |
| Report date | Aug 26, 2020 |
| Termination date | Sep 16, 2021 |
| City | Newark |
| State | NJ |
| Country | United States |
| FEI number | 2241583 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: