Z-2465-2023 Class II Ongoing
FDA device recall Z-2465-2023 was initiated by Cardiac Assist, Inc on June 30, 2023 and is designated Class II. Reason for recall: Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure, The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2023
- Initiation Date
- June 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
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
Reason for Recall
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
Distribution Pattern
US Nationwide distribution in the states of IL, FL.
Code Information
S/N and UDI: (1)Kit 5830-2916 Pump SN 00876971 UDI: ( 01)00814112020609(11)230411(17)250219(21)00876971 (2)Kit 5840-2417 Pump SN 00876972 UDI: (01)00814112020609(11)230411(17)250219(21)00876972