Recall Z-0011-2019 ยท HMX Cannula, Ophthalmic
Ellex iScience, Inc.
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
| Date | Jan 11, 2018 |
| Status | Terminated |
| Reason | Sterility failure found in one of the units in the lot. |
| Root cause | Process control |
| Action | The recalling firm called their consignees on 1/11/2018 instructing them to quarantine unused devices and monitor the patients operated with the devices in this lot. The firm issued a letter dated 1/16/2018 via FedEx Express on 1/17/2018 informing them a potential issue had been identified and to segregate the product immediately. |
| Quantity | 90 units |
| Distribution | Distribution US nationwide 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 |