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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
Recalled October 10, 2018 · FDA recall Z-0011-2019 · Ellex iScience
Hazard
Sterility failure found in one of the units in the lot. · FDA Class II
Units
90 units
Sold at
Distribution US nationwide and Switzerland.
Description
Sterility failure found in one of the units in the lot.
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.
Manufacturer(s)
Ellex iScience, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →