LivaNova recalls specific sterile disposable connectors due to potential barrier breaches in certain production batches. Affected units may have packaging issues that could compromise sterility 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 because internal tests found potential breaches in the sterile barrier. This could lead to contamination risks if the connectors are 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 the recalled connectors could face contamination risks.
Check for the insert label: 050523000/ 00803622123290 and lot number 2003400084 on the connector packaging. The product is sold under the brand LivaNova.
Look for the insert label 050523000/ 00803622123290 and lot number 2003400084 on the connector packaging.
LivaNova identified potential breaches in the sterile barrier through internal testing, which could compromise sterility during medical use.
Check the insert label and lot number on the packaging. If it matches the recalled details, contact LivaNova for further instructions.
The recall states potential barrier breaches that could lead to contamination risks, but no specific injury mechanism is described.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2453-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2453-2020 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.
