🔍 RecallPedia

FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.

Class I - Dangerous
🏥 Medical Devices Recalled: October 4, 2023 Edwards Lifesciences Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    MHD8: UDI: 00690103194609/ Lot # 64874824, 64886991, 64897466, 64982736; MHD85: UDI: 00690103194616/ Lot # 64858315; MHD6R5: UDI:07460691949737/Lot # 65008717, 65008718; MHD8R: UDI: 07460691949829/Lot # 64892236, 65009105; MHD8R5: UDI:07460691949744/Lot # 64886927; MHD8S: UDI: 07460691949805/Lot # 65048926
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Edwards Lifesciences, LLC
Reason for Recall:
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.

Product Codes/Lot Numbers:

MHD8: UDI: 00690103194609/ Lot # 64874824, 64886991, 64897466, 64982736; MHD85: UDI: 00690103194616/ Lot # 64858315; MHD6R5: UDI:07460691949737/Lot # 65008717, 65008718; MHD8R: UDI: 07460691949829/Lot # 64892236, 65009105; MHD8R5: UDI:07460691949744/Lot # 64886927; MHD8S: UDI: 07460691949805/Lot # 65048926

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0411-2024

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