HIGH

VANTIVE US Healthcare Recalls Dialyzer Over Dislodgement Risk

VANTIVE US Healthcare recalled 137,576 Prismaflex M150 Sets on January 6, 2026. The recall addresses a risk of dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

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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About This Product

The Prismaflex M150 Set is a medical device used in dialysis treatment for patients with kidney failure. It facilitates the removal of waste and excess fluid from the bloodstream during dialysis procedures.

Why This Is Dangerous

The potential dislodgement of the deaeration chamber from the control unit can compromise the device's functionality, posing serious health risks to patients relying on dialysis treatment.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients using the Prismaflex M150 Set may face serious health risks if the device malfunctions during treatment, highlighting the urgency for immediate action.

Practical Guidance

How to identify if yours is affected

  1. Check the product code on your Prismaflex M150 Set to verify if it's 109990.
  2. Look for the UDI/DI number, which should be 07332414090005.
  3. Confirm the manufacturing date is after 24F0100CA.

Where to find product info

The product code and UDI/DI number can typically be found on the packaging or the product label itself.

What timeline to expect

Expect the refund or replacement process to take approximately 4-8 weeks from the time your request is processed.

If the manufacturer is unresponsive

  • Document all correspondence with VANTIVE US Healthcare.
  • Reach out to the FDA if the company does not respond in a timely manner.
  • Consider reporting the issue through appropriate consumer safety channels.

How to prevent similar issues

  • Always check for recalls on medical devices before use.
  • Look for FDA approval and safety certifications when purchasing healthcare products.
  • Stay informed about updates from manufacturers regarding product safety.

Documentation advice

Keep a record of all communication with VANTIVE US Healthcare, including emails, letters, and phone call notes.

Product Details

The recalled product is the Prismaflex M150 Set, Product Code 109990, with UDI/DI 07332414090005. The recall affects all lots manufactured after 24F0100CA. The devices were distributed nationwide in the U.S.

Key Facts

  • Recall date: January 6, 2026
  • Reported date: February 11, 2026
  • Hazard level: High
  • Quantity recalled: 137,576 units

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
UDI/DI 07332414090005
All lots including and manufactured after 24F0100CA
Affected States
ALL
Report Date
February 11, 2026
Recall Status
ACTIVE

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