Brand
Cardiac Assist, Inc
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Cardiac Assist, Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-09-06FDA-DeviceClass IILifeSPARC 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
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
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