Fremont, CA, United States
Ellex iScience, Inc. recalls
1 recall recorded since 2018, most recently on 11 January 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 January 2018
- Terminated
- 2 October 2018
- Reason
- Sterility failure found in one of the units in the lot.
- Distribution
- Distribution US nationwide and Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0011-2019
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.