Reported Sep 6, 2023 · Ongoing
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note:…
Cardiac Assist, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardiac Assist, Inc · 240 Alpha Dr · Pittsburgh, PA · 15238-2906
Is this the product you have?
- LifeSPARC Pump (part number 5800-0000) contained within TandemLife
- LifeSPARC Priming Tray part number5800-1000
- NoteThe 5800-1000 model number is an individually packaged component
- contained within the Kit numbers5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17
- Lot codes and dates
- 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
- Amount recalled
- 2 units
Where it was sold
Why it was recalled
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
This product could cause temporary or reversible health problems — stop using it.
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