Cardiac Assist, Inc recalls LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note:…

Recall date

June 30, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2465-2023

FDA classification

Class II

Brand / firm

Cardiac Assist, Inc

Sold / distributed

US Nationwide distribution in the states of IL, FL.

Why it was recalled

Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17