Z-2590-2014Class II

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

Name: Z-2590-2014 iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid...
Creator: Ellex iScience, Inc.
Published: 2014-08-06
License: https://open.fda.gov/license/

Nova Eye Inc. / initiated 2014-08-06 / Terminated / root cause: sterility

FDA source

Ellex iScience, Inc. began a recall of iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery on 2014-08-06. FDA classified it as Class II and gives the reason as "One lot may not have been properly sealed, resulting in a non-sterile device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2590-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-06
Posted: 2014-09-04
Terminated: 2014-10-28
Recalling firm: Nova Eye Inc.
Product: iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Product code: HMX Cannula, Ophthalmic
Reason for recall: One lot may not have been properly sealed, resulting in a non-sterile device.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Recall letters were sent to all customers on August 6, 2014 by trackable mail. Letters advised on the potential lack of sterility of iTRACK250A, Canaloplasty Microcatheter Kit, lot 1404-03 due to improperly sealed pouches. Lack of sterility may pose the risk of infection to the patient. Customers are identify and segregate any affected product in their inventory. The affected product should be returned following the instructions provided. Replacement product will be provided at no charge. Questions should be directed to Customer Care at 1-888-846-4724, M-F 8 am to 4:30 Pm Eastern Time.
Quantity in commerce: 148 devices
Distribution: Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
Product codes and lots: Lot number 1404-03; Expiration: March 31, 2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2590-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2590-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-04

Product code HMX

K080067Class IIIscience Interventional Ophthalmic MicrocatheterIscience Interventional / cleared 2008-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)