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Cardiac Assist, Inc recalls LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. No
Recalled September 6, 2023 · FDA recall Z-2465-2023 · Cardiac Assist
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, · FDA Class II
Units
2 units
Sold at
US Nationwide distribution in the states of IL, FL.
Description
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
Product
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
Manufacturer(s)
Cardiac Assist, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →