What should I do if I have a recalled IV Administration Set?

Stop using the recalled IV Administration Set immediately and contact Medline Industries for further instructions on how to proceed.

How can I identify if my IV Administration Set is affected by the recall?

Check the SKU, model numbers, and lot numbers against the recall notice. Affected models include DYNJ63395B and lot numbers 25HLA435 and 25HLB046.

Will I get a refund for the recalled product?

Yes, follow the recall instructions provided by Medline Industries to initiate the return for a refund.

What are the risks associated with using a defective IV Administration Set?

Using a defective IV Administration Set can lead to improper medication or fluid administration, posing serious health risks to patients.

How can I contact Medline Industries for more information?

You can contact Medline Industries via their official website or customer service for further information regarding the recall.

Is there a deadline for returning the recalled IV Administration Sets?

Medline Industries has not specified a deadline, but it is advised to act promptly to ensure patient safety.

What are the symptoms of problems caused by faulty IV Administration Sets?

Symptoms may vary but can include adverse reactions to medication or fluid imbalances. Contact a healthcare provider if you experience any issues.

How can I ensure my new IV Administration Set is safe?

When purchasing new IV Administration Sets, check for safety certifications and ensure they are from reputable manufacturers.

What are the common issues with IV Administration Sets?

Common issues can include clogged check valves, leaks, and incorrect flow rates, which can all affect patient treatment.

Can I still use my IV Administration Set if it looks fine?

No, even if the IV Administration Set appears fine, it may still be affected by the recall. Discontinue use and contact Medline.

HIGHNovember 26, 2025

Medline Recalls IV Administration Sets Due to Sticking Valves

Medline Industries recalled 33 units of IV Administration Sets on November 26, 2025. The recall follows customer complaints about check valve components potentially becoming stuck. This defect poses a high risk to patient safety and requires immediate action from healthcare providers.

Quick Facts at a Glance

Recall Date: November 26, 2025
Hazard Level: HIGH
Brand: Medline Industries, LP
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

IV Administration Sets are medical devices used to deliver fluids and medications to patients. They are essential in various healthcare settings, including hospitals and outpatient care facilities.

Why This Is Dangerous

The recalled IV Administration Sets may have check valves that get stuck, which can disrupt proper fluid flow. This malfunction can lead to incorrect dosage delivery, which poses significant risks to patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall impacts healthcare facilities that rely on these IV Administration Sets for patient care. Immediate cessation of use may cause disruptions in treatment, necessitating replacements from alternative suppliers.

Practical Guidance

How to identify if yours is affected

Check the SKU number DYNJ63395B.
Verify the model numbers UDI/DI 10195327634698 and 40195327634699.
Look for lot numbers 25HLA435 and 25HLB046.

Where to find product info

You can typically find model and lot numbers on the packaging or the product label of the IV Administration Set.

What timeline to expect

Expect a refund or replacement processing timeline of approximately 4-6 weeks after contacting Medline.

If the manufacturer is unresponsive

Contact Medline again and document your communication.
Reach out to the FDA for further guidance on handling the recall.

How to prevent similar issues

Always check for recalls on medical devices before use.
Make sure to purchase from reputable suppliers with good safety records.
Ask healthcare providers for guidance on safe IV Administration Sets.

Documentation advice

Keep records of your correspondence with Medline, as well as any receipts or packaging related to the recalled product.

Product Details

The recall affects Medline kits containing B. Braun IV Administration Sets and Pump Administration Sets. The affected SKU is DYNJ63395B, with model numbers UDI/DI 10195327634698 and 40195327634699. Lot numbers include 25HLA435 and 25HLB046.

Key Facts

33 units recalled nationwide
Potential for serious health risks
Immediate cessation of use required
Contact Medline for further instructions

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeIV Administration Sets

Product Details

Brand

Medline Industries, LP

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