LivaNova recalls sterile vein irrigation cannulas with blunt tips due to potential sterile barrier breaches in specific packaging. Affected units have a GTIN 00803622133091 and were produced in Lot 2004900018.
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
LivaNova is recalling sterile vein irrigation cannulas with blunt tips that may have a sterile barrier breach in specific packaging. This could lead to contamination risks during medical procedures.
The sterile barrier in certain packaging may breach during use, potentially allowing contaminants to enter the bloodstream. This risk is specific to the packaging and production period mentioned in the recall.
Healthcare professionals using these cannulas for medical procedures are most at risk. Patients receiving procedures with affected cannulas may face contamination risks.
Check for the GTIN 00803622133091 on the product label. Affected units were produced in Lot 2004900018 and sold with the model ASY BIC, STERILE 25/CS.
Look for the GTIN 00803622133091 on the product label to identify affected units.
The model number is ASY BIC, STERILE 25/CS with GTIN 00803622133091.
The affected units were produced in Lot 2004900018.
The recall does not mention any remedy or fix for this issue.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2463-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2463-2020 from LivaNova. 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.
