Reported May 22, 2024 · Ongoing
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Maquet Medical Systems USA
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: Maquet Medical Systems USA · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
- Lot codes and dates
- Part No. 70104.8012 and 70104.8012R
- UDI-DI
149 of 149 codes
04037691658384Serial no. 9041002190410029904101659041025490410255904100249041002590410026904100289041003090410031904100349041003590410036904100439041004490410045904100469041004790410048904100499041005090410051904100529041005390410054904100559041005690410057904100589041005990410060904100619041006290410063904100649041006590410067904100689041006990410070904100719041007290410073904100749041007590410076904100779041007890410079904100809041008190410082904100849041008590410086904100879041008890410089
- Amount recalled
- 148 units (US: 5; OUS: 143)
Where it was sold
Why it was recalled
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
This product could cause temporary or reversible health problems — stop using it.
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