FDA Enforcement
Class II
Ongoing
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
Recall: Z-2465-2023
·
Reported September 6, 2023
Enforcement
- Recall Number
- Z-2465-2023
- Event ID
- 92748
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cardiac Assist, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 6, 2023
- Initiation Date
- June 30, 2023
- Classification Date
- August 25, 2023
- Address
- 240 Alpha Dr, N/A, Pittsburgh, PA, 15238-2906, United States
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
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
Code Info
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
Distribution
US Nationwide distribution in the states of IL, FL.
Quantity
2 units