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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HMX
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