LivaNova recalls specific sterile connectors due to potential sterile barrier breaches in certain production lots. Affected units may have packaging issues that compromise sterility during medical procedures.
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 certain sterile medical connectors that may have a breach in their sterile barrier. This could lead to contamination during medical procedures if the connector is used improperly.
The sterile barrier in certain connectors may breach during use, potentially allowing contamination. This issue is linked to specific packaging and production periods that could compromise sterility during medical procedures.
Healthcare professionals using the recalled connectors for medical procedures are most at risk. Patients receiving procedures with these connectors could face contamination risks.
Check for the lot number 2004900016 on the connector's packaging. The product has a specific insert label EC2140S/ 00803622129315 and was produced in a specific batch.
Look for the lot number 2004900016 on the connector's packaging to confirm if it's affected.
The sterile barrier in certain connectors may breach during use, potentially allowing contamination.
Check for the lot number 2004900016 on the packaging or the insert label EC2140S/ 00803622129315.
The recall record does not specify a remedy, so contact LivaNova directly for guidance.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2461-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2461-2020 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.
