FDA-Device2023-09-06Class II
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
Cardiac Assist, Inc
Hazard
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
Sold states
US Nationwide distribution in the states of IL, FL.
Affected count
2 units
Manufactured in
240 Alpha Dr, N/A, Pittsburgh, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2465-2023Don't want to check this manually?
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