LivaNova recalls specific sterile standalone connectors due to potential sterile barrier breaches in certain production lots. Affected units may have packaging issues that compromise sterility.
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 specific sterile standalone connectors that may have a breach in their sterile barrier. This could compromise sterility during medical procedures if the connector is used improperly.
The sterile barrier in certain connectors may breach during use, potentially allowing contamination. This could happen if the connector is assembled with specific packaging that has a production issue.
Healthcare professionals using these connectors for medical procedures are most at risk. Patients receiving procedures with affected connectors could face infection risks.
Check for the model number EC2102S with lot number 2004900015 on the connector's packaging. The product was sold with a specific GTIN and reference code.
Look for the model number EC2102S and lot number 2004900015 on the connector's packaging.
LivaNova identified through internal tests that the sterile barrier of certain connectors may present a breach, which could compromise sterility during medical procedures.
Check the product details for the model number EC2102S and lot number 2004900015. If you have the affected product, contact LivaNova for further instructions.
The recall states a potential breach in the sterile barrier, but does not specify a risk of serious injury or death. The hazard is described as a potential contamination risk.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2458-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2458-2020 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.
