Device recall
Z-0454-2022: iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery…
FDA device recall · Class III · Tapemark Company
Key facts
| Recall number (Z-number) | Z-0454-2022 |
|---|---|
| Recall event | 89161 |
| Product | iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min. |
| Product code | EGJ |
| Recalling firm | Tapemark Company |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 1, 2023 |
| 510(k) numbers | K992708 |
| FEI number | 2182681 |
At a glance
- 1–9 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