Ellex iScience, Inc. recalls ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit,
Recalled 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.
Hazard / Issue
Sterility failure found in one of the units in the lot.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108
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