FDA-Device2018-10-10Class II
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.
Ellex iScience, Inc.
Hazard
Sterility failure found in one of the units in the lot.
Sold states
Distribution US nationwide and Switzerland.
Affected count
90 units
Manufactured in
41316 Christy St, Fremont, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0011-2019Don't want to check this manually?
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