LivaNova recalls sterile disposable connectors with a 3/8x1/4 reducer instead of 1/2x1/2. No health risk expected as the mismatched size prevents use.
Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.
LivaNova is recalling sterile disposable connectors that sometimes came with the wrong size (3/8x1/4 instead of 1/2x1/2). This mismatch means the connector won't work properly, but it doesn't pose a health risk because the wrong size prevents use.
The recalled connectors sometimes include a smaller 3/8x1/4 reducer instead of the required 1/2x1/2 size. This mismatch prevents the connector from functioning correctly, but the wrong size makes it unusable so no health risk occurs.
Users of sterile disposable connectors for medical procedures may own affected units. Healthcare workers using these connectors are most at risk if they attempt to use the mismatched size.
Check for the item number EC2135S and lot number 1923900091 on the packaging. The affected connectors are sold in cases of 20 units.
Inspect the connector to see if it matches the 1/2x1/2 size; if not, it's part of the recall.
No significant health risk is expected because the wrong size prevents use.
Look for item number EC2135S and lot number 1923900091 on the packaging.
No, the mismatched size prevents use so it's not a safety issue.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-2642-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-2642-2020 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.
