Device recall
Z-0011-2019: ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF…
FDA device recall · Class II · Ellex iScience, Inc.
Key facts
| Recall number (Z-number) | Z-0011-2019 |
|---|---|
| Recall event | 80569 |
| Product | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery. |
| Product code | HMX |
| Recalling firm | Ellex iScience, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 2, 2018 |
| 510(k) numbers | K080067 |
| FEI number | 3005641545 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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