Device product
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Z-2590-2014
Product summary
- Event
- Event 69021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148 devices
- Official record key
device-enforcement:Z-2590-2014
Official wording
Reason: One lot may not have been properly sealed, resulting in a non-sterile device.
Code information: Lot number 1404-03; Expiration: March 31, 2016
Distribution pattern: Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
Derived failure modes
-
Unknown
One lot may not have been properly sealed, resulting in a non-sterile device.