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Ellex iScience, Inc. recalls iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion
Recalled September 10, 2014 · FDA recall Z-2590-2014 · Ellex iScience
Hazard
One lot may not have been properly sealed, resulting in a non-sterile device. · FDA Class II
Units
148 devices
Sold at
Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
Description
One lot may not have been properly sealed, resulting in a non-sterile device.
Product
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Manufacturer(s)
Ellex iScience, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →