Home / Recalls / Ellex iScience, Inc. / Z-0011-2019

Z-0011-2019 Class II Terminated

Recalled by Ellex iScience, Inc. — Fremont, CA

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