Recall Z-0011-2019— Ellex iScience, Inc.

Name: FDA recall Z-0011-2019
Creator: U.S. Food and Drug Administration
Published: 2018-01-11

Class II · Terminated

Class II FDA medical device recall by Ellex iScience, Inc., initiated 2018-01-11, terminated 2018-10-02. It names one FDA 510(k) clearance: K080067. 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: Sterility failure found in one of the units in the lot..

Recalling firm: Ellex iScience, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-01-11
Terminated: 2018-10-02
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K080067 — ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERIscience Interventional·cleared 2008-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.