FDAFDA · Food and drugs·Recall number Z-2590-2014
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Published September 10, 2014 · Recall initiated: August 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
One lot may not have been properly sealed, resulting in a non-sterile device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ellex iScience, Inc.
- Distributor
- Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
- Lot
- Lot number 1404-03; Expiration: March 31, 2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.