Ellex iScience Recalls iTRACK250A Canaloplasty Microcatheter Kits
Ellex iScience is recalling 148 iTRACK250A Canaloplasty Microcatheter Kits because one lot may not have been properly sealed, resulting in non-sterile devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may be non-sterile, posing a risk of infection or harm during surgery. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ellex iScience, Inc. is recalling 148 units of the iTRACK250A Canaloplasty Microcatheter Kit (Catalogue number: iT-250A). The devices are prescription-only, sterile instruments indicated for fluid infusion and aspiration during surgery.
The recall was initiated because one lot may not have been properly sealed, resulting in a non-sterile device. The affected lot number is 1404-03, with an expiration date of March 31, 2016.
The devices were distributed nationwide in the United States as well as in Hong Kong and Switzerland. Healthcare providers and patients should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
- Manufacturer
- Ellex iScience, Inc.
- Affected units
- 148
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot number 1404-03
- Expiration: March 31
- 2016
Distribution
Distributed nationwide across the United States.
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