LivaNova recalls sterile disposable connectors with specific GTIN and lot numbers due to potential sterile barrier breaches in certain production batches.
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 specific GTIN and lot numbers because internal tests found possible breaches in the sterile barrier. This could affect medical devices that require a sterile seal.
The sterile barrier in certain connectors may breach during use, potentially allowing contamination. This could happen if the connector is assembled with specific packaging from a particular production period.
Healthcare professionals and medical device users who have the specific connectors with GTIN 00803622123214 and lot number 2004300003 are affected. Patients using these connectors in medical procedures may be at risk.
Check for the GTIN 00803622123214 and lot number 2004300003 on the connector packaging. The product is sold under the name 'Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24'.
Look for the GTIN 00803622123214 and lot number 2004300003 on the connector packaging.
LivaNova identified through internal tests that the sterile barrier of certain connectors may present a breach, potentially affecting devices assembled with specific packaging from a particular production period.
The official recall notice does not specify a remedy or action steps beyond checking product details for the GTIN and lot number.
The recall record does not describe a specific risk of serious injury or death, 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-2446-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2446-2020 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.
