FDA recall Z-1389-2020

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.

Reason for recall

Perfusion tubing pack was packaged with the incorrect cuvette.

Distribution

US Nationwide distribution in the state of IL.

Key facts

Status

Terminated

Initiation date

2019-07-03

Report date

2020-03-04

Termination date

2021-07-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arvada, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2020