LivaNova USA Inc. recalls LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgic…
- Recall date
- July 3, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1389-2020
- FDA classification
- Class III
- Brand / firm
- LivaNova USA Inc.
- Sold / distributed
- US Nationwide distribution in the state of IL.
Why it was recalled
Perfusion tubing pack was packaged with the incorrect cuvette.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
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