Device recall
Z-2830-2020: Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary)…
FDA device recall · Class II · Pharmaceutical Innovations, Inc.
Key facts
| Recall number (Z-number) | Z-2830-2020 |
|---|---|
| Recall event | 86138 |
| 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 during the scan… |
| Product code | MUI |
| Recalling firm | Pharmaceutical Innovations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2021 |
| FEI number | 2241583 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database