ellex I.Science iTRACK 250A recall: Sterility Concern
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.…
Why was ellex I.Science iTRACK 250A recalled?
Sterility failure found in one of the units in the lot.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108
- 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.…
- Recalling firm
- Ellex iScience, Inc.
- Quantity
- 90 units
- Distribution
- Distribution US nationwide and Switzerland.
- Recall date
- October 10, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)