Z-0011-2019 Class II Terminated
FDA device recall Z-0011-2019 was initiated by Ellex iScience, Inc. on January 11, 2018 and is designated Class II. Reason for recall: Sterility failure found in one of the units in the lot. The recall status is terminated (terminated October 2, 2018). Affected quantity: 90 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- January 11, 2018
- Termination Date
- October 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 units
Product Description
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.
Reason for Recall
Sterility failure found in one of the units in the lot.
Distribution Pattern
Distribution US nationwide and Switzerland.
Code Information
Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108