LivaNova recalls sterile vein irrigation cannulas with blunt tips due to potential sterile barrier breaches in specific packaging. Affected units have a unique GTIN and lot number. Consumers should check their product labels for the recall details.
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 breach in the sterile barrier. This could lead to contamination risks during medical procedures if the cannula is used improperly.
The sterile barrier in the packaging may breach during use, potentially contaminating the cannula. This could lead to infections or other complications if the cannula is used without proper sterility.
Healthcare professionals using the recalled cannulas for medical procedures are most at risk. Patients receiving these cannulas during treatment may also be affected.
Check the product label for the GTIN: VIC/ 00803622133107 and lot number 2004300013 or 2005500214. The product is a sterile vein irrigation cannula with a blunt tip.
Look for the GTIN VIC/ 00803622133107 and lot numbers 2004300013 or 2005500214 on the packaging.
The recall states there is a potential breach in the sterile barrier, which could lead to contamination risks during medical procedures. However, the exact risk level is not specified in the notice.
Check the product label for the GTIN VIC/ 00803622133107 and lot numbers 2004300013 or 2005500214.
The recall does not specify a remedy, so the official notice does not provide instructions on what to do with the affected product.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2464-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2464-2020 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.
