iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
FDA Recall Z-2590-2014 · Posted 2014-09-04
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Recalling FirmEllex iScience, Inc.
Recall StatusTerminated
Product CodeHMX
Date Initiated2014-08-06
Date Terminated2014-10-28
Product Quantity148 devices
Reason for Recall
One lot may not have been properly sealed, resulting in a non-sterile device.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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