LivaNova recalls certain sterile standalone connectors (model EC2145S) due to potential sterile barrier breach in specific production lots. Affected units may have compromised packaging.
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 standalone connectors that could have a breach in their sterile barrier. This could affect the safety of medical procedures if the connectors are used without proper sterility.
The sterile barrier in certain connectors may breach during use, potentially compromising the sterility of medical procedures. This could lead to infections or other complications if the connectors are not properly sterilized.
Healthcare professionals using these connectors for medical procedures are most at risk. Patients receiving procedures with affected connectors could be impacted.
Check for the model EC2145S with lot numbers 2005500211 or 2004300011. These connectors were sold with specific packaging labels.
Look for the model EC2145S and lot numbers 2005500211 or 2004300011 on the connector packaging.
The recalled model is EC2145S with lot numbers 2005500211 or 2004300011.
Check for the model EC2145S with lot numbers 2005500211 or 2004300011 on the connector packaging.
The recall does not specify a remedy, so contact LivaNova for further instructions.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2462-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2462-2020 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.
