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 a risk of packaging breaches. This could lead to compromised sterility during medical procedures.
The sterile barrier in the packaging may breach during use, potentially allowing contamination. This could compromise the sterility of the medical connectors during procedures.
Medical professionals using these connectors for procedures are most at risk. Patients receiving procedures with affected connectors could face infection risks.
Check for the GTIN 00803622123320 and lot numbers 2002800191 or 2003400085 on the connector packaging. The product name includes 'Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24'.
Look for the GTIN 00803622123320 and lot numbers 2002800191 or 2003400085 on the connector packaging.
LivaNova identified through internal tests that the sterile barrier of certain connectors may breach, potentially affecting sterility.
The recall record does not specify a remedy, so check the product details and contact LivaNova for further instructions.
The recall indicates a potential breach in the sterile barrier, which could compromise sterility during medical procedures.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2455-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2455-2020 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.
