LivaNova recalls sterile disposable connectors with specific lot numbers due to potential barrier breaches in packaging. Affected units may have compromised sterility during 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 certain sterile disposable medical connectors because internal tests found a risk of packaging breaches. This could lead to contamination if the connectors are used in medical procedures.
The sterile barrier in the packaging may breach during use, potentially allowing contamination. This issue is linked to specific production periods and packaging configurations.
Healthcare professionals and medical facilities using the recalled connectors for procedures are most at risk. Patients receiving treatments with these connectors may face contamination risks.
Check for the lot number 2003400088 on the connector packaging. The product has a specific GTIN: 00803622123382 and was sold with the insert label 050608000.
Verify the lot number on the connector packaging to confirm if it matches 2003400088.
The lot number for this recall is 2003400088.
Check for the lot number 2003400088 on the packaging or the GTIN 00803622123382 with insert label 050608000.
The recall record does not specify any remedy or action steps beyond checking the product details.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2457-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2457-2020 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.
