Drug recall
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on…
FDA recall event 80569 · Class II · Ellex iScience, Inc.
Key facts
| Event ID | 80569 |
|---|---|
| Recall numbers | Z-0011-2019 |
| Recalling firm | Ellex iScience, Inc. |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sterility failure found in one of the units in the lot. |
| Initiation date | Jan 11, 2018 |
| Report date | Oct 10, 2018 |
| Termination date | Oct 2, 2018 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 3005641545 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: