Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall iTRACK

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall iTRACK see related information
Date Initiated by Firm August 06, 2014
Date Posted September 04, 2014
Recall Status1 Terminated 3 on October 28, 2014
Recall Number Z-2590-2014
Recall Event ID 69021
510(K)Number K080067  
Product Classification Cannula, ophthalmic - Product Code HMX
Product iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile.

Indicated for fluid infusion and aspiration during surgery.
Code Information Lot number 1404-03; Expiration: March 31, 2016
Recalling Firm/
Manufacturer		 Ellex iScience, Inc.
4055 Campbell Ave
Menlo Park CA 94025-1006
For Additional Information Contact Lisa Sims
650-421-2757
Manufacturer Reason
for Recall		 One lot may not have been properly sealed, resulting in a non-sterile device.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HMX and Original Applicant = ISCIENCE INTERVENTIONAL
-
-