What product is being recalled?

The recall covers the IV administration set catalog 470005 used with BBMI Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. It concerns backflow risk and occlusion during priming.

Which units are affected?

29,900 units distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

How can I identify the affected product?

Check the packaging for Catalog Number 470005 and verify the Primary UDI-DI 04046964297199 and Unit of Dose UDI-DI 04046964297182.

What should I do if I own this product?

Stop using the device immediately. Follow the manufacturer’s recall instructions and contact B. Braun Medical or your healthcare provider for guidance.

Is it safe to use any IV sets from BBMI after the recall?

No. The recall specifically addresses this set and you should discontinue its use until instructed otherwise.

How will refunds or replacements be issued?

Follow the recall instructions from the manufacturer to arrange refunds or replacements. Details will be provided by the company.

Where can I find official recall notices?

The FDA enforce page and recall notice provide official details. The recall number is Z-0658-2026.

Will hospitals be notified?

Recall notices are distributed to healthcare providers and institutions via formal recall communications.

What caused the recall?

Backflow from secondary IV containers into primary containers and an occlusion that prevents priming.

If I am in a healthcare setting, what should we do now?

Quarantine the affected stock and follow the manufacturer’s instructions for handling, replacements, or refunds.

How long will refunds take?

Processing times are not specified in the recall notice. Check with the manufacturer for a timeline.

What if I disposed of the product already?

Contact the manufacturer for instructions on disposition and any possible remedies.

HIGHOctober 29, 2025

B. Braun Medical IV Administration Set Recall for 29,900 Units Over Backflow and Occlusion Risk (202

B. Braun Medical recalled 29,900 IV administration sets distributed worldwide through medical distributors. The recall is linked to backflow from secondary to primary IV containers and an inability to prime. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.

Quick Facts at a Glance

Recall Date: October 29, 2025
Hazard Level: HIGH
Brand: B. Braun Medical
Category: Health & Personal Care
Sold At: Multiple Retailers
At-Risk Groups: GENERAL

Hazard Information

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter

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About This Product

IV administration sets are used to deliver medications and fluids via IV lines. They connect primary IV routes to secondary piggyback containers and are used in hospitals and clinics.

Why This Is Dangerous

This recall concerns a risk of backflow from a piggyback container into the primary IV line and an occlusion that prevents priming, potentially affecting medication delivery.

Industry Context

This recall is not stated as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics using the affected set must halt use to prevent misdelivery or interruption of IV therapy. Financial impact includes potential refunds or replacements for 29,900 units.

Practical Guidance

How to identify if yours is affected

Check packaging for Catalog Number 470005
Verify Primary UDI-DI 04046964297199
Verify Unit of Dose UDI-DI 04046964297182
If matched, stop use immediately
Contact the manufacturer for refund/replacement details

Where to find product info

Refer to the recall page and FDA enforcement report for official identifiers and instructions

What timeline to expect

Refunds or replacements timelines are not specified in the recall notice

If the manufacturer is unresponsive

Escalate with hospital procurement or regulatory body
Document all communications
Consider seeking guidance from patient safety offices

How to prevent similar issues

For future purchases, verify UDI codes on-label and ensure recall status is checked before use
Only purchase from authorized medical distributors
Maintain a recall monitoring routine for medical devices

Documentation advice

Keep the recall notice, packing, and any incident reports; document lot numbers and UDI codes for internal records

Product Details

Catalog Number: 470005 Primary UDI-DI: 04046964297199 Unit of Dose UDI-DI: 04046964297182 Quantity: 29,900 units Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore) Sold: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

29,900 units recalled
Catalog Number 470005
Primary UDI-DI 04046964297199
Unit of Dose UDI-DI 04046964297182
Worldwide distribution

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 Set (gravity and pump)

Product Details

Brand

B. Braun Medical

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