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 procedures.
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 Connectors that may have a breach in their sterile barrier. This could lead to contamination risks if used in medical procedures, so affected users should check their product details.
The sterile barrier in certain connectors may breach during use, potentially allowing contamination. This issue is linked to specific packaging and production periods, which could compromise the connector's sterility during medical procedures.
Healthcare professionals and medical facilities using the recalled connectors for procedures are most at risk. Patients using these connectors during medical treatments could face contamination risks.
Check for the product label: 050505000/ 00803622123238. The affected lot number is 2004900013. These connectors were produced during a specific period and packaged with certain materials.
Look for the label: 050506000/ 00803622123238 on the connector packaging.
The sterile barrier of certain connectors may breach, potentially leading to contamination risks during medical procedures.
Check for the label: 050506000/ 00803622123238 and lot number 2004900013 on the connector packaging.
The recall does not specify a remedy, so contact LivaNova for guidance on next steps.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2449-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2449-2020 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.
