LivaNova recalls certain Sterile Disposable Connectors due to potential sterile barrier breaches in specific production lots. Affected units may pose infection risks during medical procedures. Consumers should check product labels for the lot number 2003400086.
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 infection risks during medical procedures if the connectors are used improperly.
The sterile barrier in certain connectors may breach during use, potentially allowing contaminants to enter medical procedures. This issue is linked to specific production lots and packaging configurations.
Healthcare professionals using these connectors for medical procedures are most at risk. Patients receiving procedures with affected connectors could face infection risks.
Check the product label for the lot number 2003400086. The connectors have a specific GTIN: 00803622123351 and are part of the ASY RDC Y 1/2X3/8X3/8 STR 24 series.
Look for the lot number 2003400086 on the connector packaging.
The recall indicates a potential breach risk in specific production lots, so affected units should not be used until the remedy is applied.
Check the product label for the lot number 2003400086. If it matches, contact LivaNova for instructions.
The recall record does not specify a remedy, so affected users should contact LivaNova directly for guidance.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2456-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2456-2020 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.
