ellex I.Science iTRACK 250A, Canaloplasty Microcatheter… recallZ-0011-2019 · Ellex iScience, Inc. · initiated Jan 11, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ellex iScience, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterility failure found in one of the units in the lot.
FDA root cause category: Process control
What the company is doing
The recalling firm called their consignees on 1/11/2018 instructing them to quarantine unused devices and monitor the patients operated with the devices in this lot. The firm issued a letter dated 1/16/2018 via FedEx Express on 1/17/2018 informing them a potential issue had been identified and to segregate the product immediately.
Recall details
- Recall number
- Z-0011-2019
- Status
- Terminated
- Initiated by the company
- Jan 11, 2018
- Recalling firm
- Ellex iScience, Inc.
- Quantity
- 90 units
- Product code
- HMX
- FDA submissions
- K080067
- Distribution
- Distribution US nationwide and Switzerland.
Product description
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.
Code information (models, lots, serial numbers)
Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- iTrack 250ANova Eye, Inc. · Cannula, Ophthalmic1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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