Z-2590-2014 Class II Terminated
FDA device recall Z-2590-2014 was initiated by Ellex iScience, Inc. on August 6, 2014 and is designated Class II. Reason for recall: One lot may not have been properly sealed, resulting in a non-sterile device. The recall status is terminated (terminated October 28, 2014). Affected quantity: 148 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2014
- Initiation Date
- August 6, 2014
- Termination Date
- October 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 148 devices
Product Description
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Reason for Recall
One lot may not have been properly sealed, resulting in a non-sterile device.
Distribution Pattern
Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
Code Information
Lot number 1404-03; Expiration: March 31, 2016