iTRACK250A Canaloplasty Microcatheter Kit recall: Sterility Concern
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Why was iTRACK250A Canaloplasty Microcatheter Kit recalled?
One lot may not have been properly sealed, resulting in a non-sterile device.
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 number 1404-03; Expiration: March 31, 2016
- Product
- iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
- Recalling firm
- Ellex iScience, Inc.
- Quantity
- 148 devices
- Distribution
- Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
- Recall date
- September 10, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)