LivaNova recalls sterile disposable connectors with specific model and lot numbers due to potential barrier breaches in packaging. Affected units may have compromised sterility during 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 certain sterile disposable medical connectors because internal tests found a risk of packaging breaches. This could lead to contamination during medical procedures if the connectors are used without proper sterility.
The sterile barrier in the packaging may breach during manufacturing or handling, potentially allowing contaminants to enter the connector. This could compromise the sterility required for medical use.
Healthcare professionals using these connectors for medical procedures are most at risk. Patients receiving procedures with affected connectors could face contamination risks.
Check for the model number ASY S/1/4 TO 3/16 RED 24 REF/ GTIN with insert label 050514000/00803622123269. The affected lot number is 2004300006.
Look for the model number ASY S/1/4 TO 3/16 RED 24 REF/ GTIN with insert label 050514000/00803622123269 and lot number 2004300006.
The specific model is ASY S/1/4 TO 3/16 RED 24 REF/ GTIN with insert label 050514000/00803622123269.
The recall indicates a potential packaging breach, which could lead to contamination during medical procedures, but no specific injury risk is stated.
Check for the model number and insert label 050514000/00803622123269 with lot number 2004300006.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2450-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2450-2020 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.
