Reported Sep 10, 2014 · Terminated
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion…
Ellex iScience, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ellex iScience, Inc. · 4055 Campbell Ave · Menlo Park, CA · 94025-1006
Is this the product you have?
- iTRACK250A Canaloplasty Microcatheter Kit
- Catalogue numberiT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery
- Lot codes and dates
- Lot number 1404-03
- Expiration
March 312016
- Amount recalled
- 148 devices
Where it was sold
- Nationwide
Why it was recalled
One lot may not have been properly sealed, resulting in a non-sterile device.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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