FDAJanuary 11, 2018device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Sterility failure found in one of the units in the lot.
What to do
FDA enforcement status: Terminated
Brands named
ellex iscienceellex
UPCs
00893872001059
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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