🔍 RecallPedia

PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Class I - Dangerous
🏥 Medical Devices Recalled: January 6, 2026 VANTIVE US HEALTHCARE Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI 07332414111038, All lots including and manufactured after 24J0106
  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:
VANTIVE US HEALTHCARE LLC
Reason for Recall:
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Product Codes/Lot Numbers:

UDI/DI 07332414111038, All lots including and manufactured after 24J0106

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1231-2026

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