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 sterile disposable connectors with a specific GTIN and lot number because internal tests found a possible breach in the sterile barrier. This could mean the connectors aren't safe for medical use.
The sterile barrier in the connectors might not be intact, which could lead to contamination. This issue is linked to specific packaging and production periods.
Medical professionals using these connectors for procedures are most at risk. Patients receiving treatments with these connectors could be affected.
Check for the GTIN 00803622123306 and lot number 2002800190 on the connector packaging. The product was sold with the insert label 050524000.
Look for the GTIN 00803622123306 and lot number 2002800190 on the connector packaging.
LivaNova identified through internal tests that the sterile barrier of certain connectors may have a breach, which could affect the packaging and production.
The recall record does not specify a remedy, so check the product details and contact LivaNova for further instructions.
The recall record does not describe a specific injury risk, so the danger level is unknown.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2454-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2454-2020 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.
