LivaNova recalls specific sterile standalone connectors (model EC2130S, lot 2004300009) due to potential sterile barrier breaches in certain packaging. Affected units may have compromised 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 (model EC2130S, lot 2004300009) because internal tests found potential breaches in the sterile barrier. This could compromise sterility during medical procedures.
The sterile barrier in certain connectors might breach during assembly with specific packaging. This could compromise sterility during medical procedures if the breach occurs.
Healthcare professionals using these connectors in medical procedures may be affected. Patients undergoing surgery with these connectors could face sterility risks.
Check for the model EC2130S and lot number 2004300009 on the connector's packaging. The product was sold with a specific insert label.
Identify the model EC2130S and lot number 2004300009 on the connector's packaging.
The recalled connectors are model EC2130S with lot number 2004300009.
Internal tests by LivaNova found potential breaches in the sterile barrier of certain connectors.
The recall record does not specify a remedy.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2460-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2460-2020 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.
