Recall Z-2590-2014
Ellex iScience, Inc. · initiated August 6, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Codes / lots: Lot number 1404-03; Expiration: March 31, 2016
Reason for recall
One lot may not have been properly sealed, resulting in a non-sterile device.
FDA-determined cause: Under Investigation by firm
Action taken
Urgent Medical Device Recall letters were sent to all customers on August 6, 2014 by trackable mail. Letters advised on the potential lack of sterility of iTRACK250A, Canaloplasty Microcatheter Kit, lot 1404-03 due to improperly sealed pouches. Lack of sterility may pose the risk of infection to the patient. Customers are identify and segregate any affected product in their inventory. The affected product should be returned following the instructions provided. Replacement product will be provided at no charge. Questions should be directed to Customer Care at 1-888-846-4724, M-F 8 am to 4:30 Pm Eastern Time.
Details
- Recall number
- Z-2590-2014
- Initiated
- August 6, 2014
- Posted by FDA
- September 4, 2014
- Terminated
- October 28, 2014
- Product code
- HMX – Cannula, Ophthalmic
- Quantity
- 148 devices
- Distribution
- Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
- Recalling firm
- Ellex iScience, Inc., Menlo Park, CA