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LivaNova USA Inc. recalls LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgica
Recalled March 4, 2020 · FDA recall Z-1389-2020 · LivaNova USA
Hazard
Perfusion tubing pack was packaged with the incorrect cuvette. · FDA Class III
Units
27 packs
Sold at
US Nationwide distribution in the state of IL.
Description
Perfusion tubing pack was packaged with the incorrect cuvette.
Product
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.
Manufacturer(s)
LivaNova USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →