FDA recall Z-0011-2019

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.

Reason for recall

Sterility failure found in one of the units in the lot.

Distribution

Distribution US nationwide and Switzerland.

Key facts

Status

Terminated

Initiation date

2018-01-11

Report date

2018-10-10

Termination date

2018-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0011-2019