Reported Jul 29, 2020 · Terminated

LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case

LivaNova USA Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: LivaNova USA Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503

Is this the product you have?

    • LivaNova USA Sterile Disposable Connector
    • 1/2x1/2
    • 20 units per case
Lot codes and dates
    • Item# EC2135S
    • Lot No. 1923900091
Amount recalled
140 units

Where it was sold

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 19, 2021 · Data as of Sep 19, 6:56 PM UTC

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