HIGH

VANTIVE US HEALTHCARE Recalls Dialyzer Over Dislodgement Risk

VANTIVE US HEALTHCARE recalled 115,112 units of the PRISMAFLEX HF1000 SET on January 6, 2026. The recall stems from a potential dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.

Quick Facts at a Glance

Recall Date
January 6, 2026
Hazard Level
HIGH
Brand
VANTIVE US HEALTHCARE
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact VANTIVE US HEALTHCARE LLC or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the PRISMAFLEX HF1000 SET, Product Code 107142. It includes all lots manufactured after 24F0094CA and has a UDI/DI of 07332414069315. The device was distributed nationwide in the United States.

The Hazard

The potential dislodgement of the deaeration chamber poses a significant risk to patients relying on this medical device. This issue could disrupt the dialysis process, leading to severe health complications.

Reported Incidents

Currently, there are no specific incident reports or injuries associated with this recall. However, the hazard level is classified as high due to the potential impact on patient health.

What to Do

Patients and healthcare providers should stop using the device immediately. Follow the manufacturer's recall instructions and contact VANTIVE US HEALTHCARE LLC for guidance.

Contact Information

For more information, contact VANTIVE US HEALTHCARE LLC. Visit the FDA website for additional details about the recall.

Key Facts

  • 115,112 units recalled
  • Potential dislodgement risk
  • Class II recall
  • Stop using the device immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
9/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UDI/DI 07332414069315
All lots including and manufactured after 24F0094CA
Affected States
ALL
Report Date
February 11, 2026
Recall Status
ACTIVE

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