Ellex iScience recalls iTRACK 250A Canaloplasty Microcatheter Kits (REF iT-250A) due to sterility failure in one unit. Affected kits were sold with lot number 1711-08, expiring 11/1/2019. Contact for return instructions.
Sterility failure found in one of the units in the lot.
Ellex iScience is recalling its iTRACK 250A Canaloplasty Microcatheter Kit for single use due to a sterility failure found in one unit of the lot. This could lead to infection if the kit is used in ophthalmic surgery.
The recall is for a single unit in a lot where sterility failure was detected. This means the kit could become contaminated during use, potentially causing infection in patients during ophthalmic surgery.
Ophthalmic surgeons and medical facilities using the iTRACK 250A kit for canaloplasty procedures. Patients undergoing surgery with this kit are at risk of infection if the kit is not sterile.
Check for the product name 'iTRACK 250A Canaloplasty Microcatheter Kit' with reference number iT-250A. The lot number is 1711-08 and expiration date is November 1, 2019.
Look for the lot number 1711-08 and expiration date of November 1, 2019 on the kit's label.
The recall indicates sterility failure in one unit of the lot, so it is not safe to use without checking the recall status.
Check the kit's label for lot number 1711-08 and expiration date of November 1, 2019.
The recall does not specify a remedy, so contact Ellex iScience for further instructions.
We’ve drafted a message you can send Ellex iScience to request your refund or repair — edit it as you like.
Subject: Recall Z-0011-2019 — Ellex iScience Ellex iScience Hello, I own a Ellex iScience that is covered by recall Z-0011-2019 from Ellex iScience. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
