LivaNova recalls sterile disposable connectors with specific GTIN and lot numbers due to potential barrier breaches in 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 certain sterile disposable medical connectors because internal tests found possible breaches in their sterile packaging. This could mean the connectors aren't as clean as they should be, which might cause infections during medical procedures.
The sterile barrier in the packaging might not seal properly during manufacturing, leading to contamination. This could happen with specific production batches and packaging types, potentially making the connectors unsafe for medical use.
Healthcare professionals using these connectors for medical procedures are most at risk. Patients receiving procedures with these connectors could be affected if the sterility is compromised.
Check for the GTIN label 050518000/ 00803622123283 and lot number 2003400083 on the connector packaging. The product is a sterile disposable medical connector with specific dimensions.
Look for the GTIN label 050518000/ 00803622123283 and lot number 2003400083 on the connector packaging.
LivaNova identified through internal tests that the sterile barrier of certain connectors may have a breach, which could affect sterility.
Check for the GTIN label 050518000/ 00803622123283 and lot number 2003400083 on the connector packaging.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2452-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2452-2020 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.
