medical Class III Updated 2020-03-04

LivaNova USA Inc. recalls LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: Th

Recalled 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.

Hazard / Issue

Perfusion tubing pack was packaged with the incorrect cuvette.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: 046008200 Lot Number: 1912100141 UDI: (01)00803622140136(240)046008200 (17)210430(10)1912100141 Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette
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