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U.S. Department of Health and Human Services

Class 2 Device Recall ellex I.Science iTRACK 250A

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  Class 2 Device Recall ellex I.Science iTRACK 250A see related information
Date Initiated by Firm January 11, 2018
Create Date October 01, 2018
Recall Status1 Terminated 3 on October 02, 2018
Recall Number Z-0011-2019
Recall Event ID 80569
510(K)Number K080067  
Product Classification Cannula, ophthalmic - Product Code HMX
Product 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.
Code Information Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108
Recalling Firm/
Manufacturer		 Ellex iScience, Inc.
41316 Christy St
Fremont CA 94538-3115
Manufacturer Reason
for Recall		 Sterility failure found in one of the units in the lot.
FDA Determined
Cause 2		 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 in Commerce 90 units
Distribution Distribution US nationwide and Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HMX and Original Applicant = ISCIENCE INTERVENTIONAL
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