Recall Z-2590-2014— Ellex iScience, Inc.

Name: FDA recall Z-2590-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-06

Class II · Terminated

Class II FDA medical device recall by Ellex iScience, Inc., initiated 2014-08-06, terminated 2014-10-28. It names one FDA 510(k) clearance: K080067. Product: iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.. Reason: One lot may not have been properly sealed, resulting in a non-sterile device..

Recalling firm: Ellex iScience, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-06
Terminated: 2014-10-28
Firm location: Menlo Park, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K080067 — ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERIscience Interventional·cleared 2008-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.