LivaNova recalls certain Sterile Disposable Connectors due to potential sterile barrier breaches in specific production lots. Affected units may have compromised packaging that could lead to contamination risks during medical procedures.
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 risks if used in medical procedures, so affected users should stop using these items immediately.
The sterile barrier in certain connectors may breach during use, potentially allowing contamination. This issue is linked to specific packaging and production periods that could compromise the connector's sterility.
Healthcare professionals and medical facilities using the recalled connectors for procedures are most at risk. Patients receiving treatments with these connectors could face contamination risks.
Check for the product label with GTIN 00803622123184 or the specific lot number 2002800186. The connectors are used in medical procedures and may have been sold with the insert label 050432000.
Immediately stop using the recalled connectors as they may have a breached sterile barrier.
The specific model is ASY 3/16 X 3/16 STR CONNW/LL24 with GTIN 00803622123184 and lot number 2002800186.
LivaNova identified through internal tests that the sterile barrier of certain connectors may breach, potentially leading to contamination risks during medical procedures.
Check for the GTIN 00803622123184 or lot number 2002800186 on the connector label.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2444-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2444-2020 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.
