FDA-Device2014-09-10Class II
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Ellex iScience, Inc.
Hazard
One lot may not have been properly sealed, resulting in a non-sterile device.
Sold states
Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
Affected count
148 devices
Manufactured in
4055 Campbell Ave, Menlo Park, CA, United States
Products
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2590-2014Don't want to check this manually?
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