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.
FDA Recall Z-0011-2019 · Posted None
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Recalling FirmEllex iScience, Inc.
Recall StatusTerminated
Product CodeHMX
Date Initiated2018-01-11
Date Terminated2018-10-02
Product Quantity90 units
Reason for Recall
Sterility failure found in one of the units in the lot.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Distribution US nationwide and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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