FDA Device Recall Z-0011-2019: Ellex iScience, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0011-2019.

Recall Res Number

Z-0011-2019

Recalling Firm / Manufacturer

Ellex iScience, Inc.

FEI Number

3005641545

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2018-01-11

Date Posted

N/A

Date Terminated

2018-10-02

Product Code

HMX

Event Number

80569

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.

Action Details 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.

Distribution Pattern Distribution US nationwide and Switzerland.

Code Information / Serial Numbers Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108

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Medical Device Recall: Z-0011-2019

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer