LivaNova recalls specific sterile disposable connectors due to potential barrier breaches in certain production batches. Affected units may have packaging issues that could compromise 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 specific sterile disposable connectors that may have a breach in their sterile barrier. This could lead to contamination if the connectors are used in medical procedures.
The sterile barrier in certain connectors may breach during use, potentially allowing contamination. This issue is linked to specific packaging and production batches.
Healthcare professionals using these connectors for medical procedures are most at risk. Patients receiving procedures with affected connectors could face contamination.
Check for the model number 3/8 X 1/4 24 REF with GTIN 00803622123276 and lot number 2003400082. The product was sold with an insert label starting with 050516000.
Identify the model number, GTIN, and lot number to confirm if your connector is affected.
The model number is 3/8 X 1/4 24 REF with GTIN 00803622123276 and lot number 2003400082.
Check for the model number 3/8 X 1/4 24 REF with GTIN 00803622123276 and lot number 2003400082 on the packaging.
The recall does not specify a remedy, so contact LivaNova for further instructions.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2451-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2451-2020 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.
