Home / Recalls / LivaNova USA Inc. / Z-1389-2020

Z-1389-2020 Class III Terminated

Recalled by LivaNova USA Inc. — Arvada, CO

Recall Details

Product Type
Devices
Report Date
March 4, 2020
Initiation Date
July 3, 2019
Termination Date
July 9, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27 packs

Product Description

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.

Reason for Recall

Perfusion tubing pack was packaged with the incorrect cuvette.

Distribution Pattern

US Nationwide distribution in the state of IL.

Code Information

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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