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 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 medical connectors that may have a breach in their sterile barrier. This could lead to contamination risks 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 periods that could compromise the connector's sterility.
Medical professionals and hospitals using the recalled connectors for procedures are most at risk. Patients using these connectors during medical treatments could face contamination risks.
Check for the connector model ASY S CONN 3/16X1/8 RDR ANLD24 with the insert label 050513000 and GTIN 00803622123252. The affected lot number is 2002800189.
Verify the connector model, insert label, and lot number to confirm if it matches the recalled items.
LivaNova identified through internal tests that the sterile barrier in certain connectors may breach, potentially affecting component assembly and packaging.
The recall record does not specify a remedy, so check product details to confirm if it's affected and contact LivaNova for further guidance.
The recall indicates potential contamination risks but does not mention serious injury or death, so the risk level is low.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2448-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2448-2020 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.
