Device recall
Z-0194-2022: IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L…
FDA device recall · Class I · Lumenis, Inc.
Key facts
| Recall number (Z-number) | Z-0194-2022 |
|---|---|
| Recall event | 88863 |
| Product | IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical |
| Product code | ITX |
| Recalling firm | Lumenis, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 12, 2024 |
| 510(k) numbers | K955246 |
| FEI number | 1720381 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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