Reported Dec 6, 2023 · Ongoing
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure…
Edwards Lifesciences, LLC
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: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- FloTrac Sensor
- REFMHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 00690103194609UDI: 00690103194609/ Lot # 64874824, 64886991, 64897466, 64982736 2 00690103194616MHD85: UDI: 00690103194616/ Lot # 64858315 3 07460691949737MHD6R5: UDI:07460691949737/Lot # 65008717, 65008718 4 07460691949829MHD8R: UDI: 07460691949829/Lot # 64892236, 65009105 5 07460691949744MHD8R5: UDI:07460691949744/Lot # 64886927 6 07460691949805MHD8S: UDI: 07460691949805/Lot # 65048926 - Amount recalled
- 1417 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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