iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and
FDA device recall Z-2590-2014 · posted 2014-09-04 · Terminated
Recall details
- Recalling firm
- Ellex iScience, Inc.
- Reason for recall
- One lot may not have been properly sealed, resulting in a non-sterile device.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- HMX
- Quantity affected
- 148 devices
- Distribution
- Worldwide Distribution -- US (nationwide) and countries of: Hong Kong and Switzerland.
- Date initiated
- 2014-08-06
- Date posted
- 2014-09-04
- Date terminated
- 2014-10-28
- Location
- Menlo Park, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER (K080067) | Iscience Interventional | 2008-07-18 |