FDA-Device2020-03-04Class III
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.
LivaNova USA Inc.
Hazard
Perfusion tubing pack was packaged with the incorrect cuvette.
Sold states
US Nationwide distribution in the state of IL.
Affected count
27 packs
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2020Don't want to check this manually?
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