The Recall Desk
HighFDA (Devices)·Z-0011-2019·Announced 2018-10-10

Ellex iScience Recalls Canaloplasty Microcatheter Kits Due to Sterility Failure

Ellex iScience is recalling 90 units of the iTRACK 250A Canaloplasty Microcatheter Kit because a sterility failure was found in one unit of the lot.

What this means for you

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 is classified as FDA Class II. The hazard involves a sterility failure in a surgical device, which poses a risk of infection (risk-of-harm), but the source text does not report any specific illnesses or injuries, placing it in the 'High' severity category per the rubric.

Plain-English summary

Ellex iScience, Inc. is recalling 90 units of the ellex I.Science iTRACK 250A Canaloplasty Microcatheter Kit, REF iT-250A. The product is a single-use medical device used in ophthalmic surgery. The recall is being conducted because a sterility failure was identified in one of the units within the affected lot.

The affected lot is 1711-08, with an expiration date of 11/1/2019. The UDI for the product is (01)00893872001059(17)191101(10)171108. The product was distributed nationwide in the United States and in Switzerland.

Healthcare providers and patients should stop using the affected product and contact Ellex iScience, Inc. for further instructions or a replacement. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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.
Manufacturer
Ellex iScience, Inc.
Category
Medical Device — Ophthalmic Surgical Device
Hazard
Affected units
90

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 1711-08
  • Exp. 11/1/2019
  • UDI (01)00893872001059(17)191101(10)171108

Distribution

Distributed nationwide across the United States.

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