ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ellex iScience, Inc.
- Reason for Recall:
- Sterility failure found in one of the units in the lot.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Product Codes/Lot Numbers:
Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0011-2019
Related Recalls
Class I - Dangerous
One lot may not have been properly sealed, resulting in a non-sterile device.