Device recall
Z-2480-2021: EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200…
FDA device recall · Class I · AMTEC SALES Inc
Key facts
| Recall number (Z-number) | Z-2480-2021 |
|---|---|
| Recall event | 88584 |
| Product | EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an… |
| Product code | ITX |
| Recalling firm | AMTEC SALES Inc |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K955246, K961757, K962840 |
| FEI number | 3018301188 |
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