# FDA recall Z-0011-2019

> **Ellex iScience, Inc.** · Class II · device recall initiated 2018-01-11.

## 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.

## Reason for recall

Sterility failure found in one of the units in the lot.

## Distribution

Distribution US nationwide and Switzerland.

## Key facts

- **Recall number:** Z-0011-2019
- **Recalling firm:** Ellex iScience, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-11
- **Report date:** 2018-10-10
- **Termination date:** 2018-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0011-2019

## Citation

> AI Analytics. FDA recall Z-0011-2019. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0011-2019. Source: US FDA. Licensed CC0.

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