Ellex iScience, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2590-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.

Product Classification:

Class II

Date Initiated: August 6, 2014

Date Posted: September 10, 2014

Recall Number: Z-2590-2014

Event ID: 69021

Reason for Recall:

One lot may not have been properly sealed, resulting in a non-sterile device.

Status: Terminated

Product Quantity: 148 devices

Code Information:

Lot number 1404-03; Expiration: March 31, 2016

Distribution Pattern:

Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated