Recall Z-2590-2014 ยท HMX Cannula, Ophthalmic
Ellex iScience, Inc.
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
| Date | Sep 4, 2014 (initiated Aug 6, 2014) |
| Status | Terminated |
| 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 |
| Quantity | 148 devices |
| Distribution | Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080067 | ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER Iscience Interventional, Jul 18, 2008 |