LivaNova recalls certain Sterile Disposable Connectors due to potential sterile barrier breaches in specific production lots. Affected units may have compromised packaging that could lead to contamination risks during medical use.
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 disposable medical connectors that may have a breach in their sterile barrier. This could lead to contamination risks if used in medical procedures.
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 the connector's sterility.
Healthcare professionals using these connectors for medical procedures are most at risk. Patients receiving procedures with these connectors may face contamination risks.
Check for the lot number 2003400081 on the connector's packaging. The product has a specific GTIN: 00803622123207 and is sold under the reference 050434000.
Look for the lot number 2003400081 on the connector's packaging or label.
The affected lot number is 2003400081.
Check for the lot number 2003400081 on the connector's packaging or label.
The recall record does not mention any remedy or fix.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2445-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2445-2020 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.
