LivaNova recalls sterile disposable connectors with specific GTIN and lot numbers due to potential sterile barrier breaches. 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 disposable medical connectors because internal tests found a risk of sterile barrier breaches. 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 manufacturing, potentially compromising the packaging. This could lead to contamination if the connectors are used without proper sterility.
Healthcare professionals and medical facilities using the specific connectors with the listed GTIN and lot numbers are most at risk. Patients receiving procedures using these connectors could be affected.
Check for the GTIN 00803622123221 and lot number 2004300004 on the connector packaging. The product name is Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24.
Look for the GTIN 00803622123221 and lot number 2004300004 on the connector packaging.
LivaNova identified through internal tests that the sterile barrier of certain connectors may present a breach, potentially affecting component assembly and packaging.
Check the packaging for the GTIN 00803622123221 and lot number 2004300004. If it matches, stop using it and contact LivaNova for guidance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2447-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2447-2020 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.
