Reported Oct 10, 2018 · Terminated
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the…
Ellex iScience, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ellex iScience, Inc. · 41316 Christy St · Fremont, CA · 94538-3115
Is this the product you have?
- 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.
- Lot codes and dates
Lot 1711-08Exp. 11/1/2019UDI (01)00893872001059(17)191101(10)171108
- Amount recalled
- 90 units
Where it was sold
- Nationwide
Why it was recalled
Sterility failure found in one of the units in the lot.
This product could cause temporary or reversible health problems — stop using it.
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