Ellex iScience, Inc. recalls ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the labe…

Recall date

January 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0011-2019

FDA classification

Class II

Brand / firm

Ellex iScience, Inc.

Sold / distributed

Distribution US nationwide and Switzerland.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.