FDA Device recall Z-2590-2014
iTRACK250A Canaloplasty Microcatheter Kit
- FDA Device
- Class II
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class II recall of iTRACK250A Canaloplasty Microcatheter Kit by Ellex Iscience, citing one lot may not have been properly sealed, resulting in a non-sterile device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2590-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-06 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ellex Iscience |
| Distribution | US |
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.
Identifiers
| code_info | Lot number 1404-03; Expiration: March 31, 2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2590-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.