FDA Medical Device Recalls (openFDA)
Ellex iScience, Inc.: iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
- Recall number
- Z-2590-2014
- Recalling firm
- Ellex iScience, Inc.
- Product
- iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
- Status
- Terminated
- Initiated
- 2014-08-06
- Posted
- 2014-09-04
- Terminated
- 2014-10-28
- Reason
- One lot may not have been properly sealed, resulting in a non-sterile device.
- 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
- 148 devices
- Distribution
- Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
- Lot, serial or model codes
- Lot number 1404-03; Expiration: March 31, 2016
- 510(k) numbers
- ["K080067"]
- PMA numbers
- not on file
- Product code
- HMX
- Firm FEI
- 3005641545
- Firm city
- Menlo Park
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28