HIGHFDA DEVICE

B. Braun Medical Infusion Extension Set Recall for 11,650 Units Over Backflow Risk (2025)

B. Braun Medical recalls 11,650 extension sets used with Infusomat Space pumps sold worldwide after a backflow and priming defect. The device can allow medication to flow from a piggyback container into the primary line and may not prime properly. Hospitals and patients should stop using the device immediately and follow recall instructions from the manufacturer.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
October 29, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
B Braun Medical
Product type
IV Extension Set
Model numbers
AS152V2DLL, 473309
Sold at
Multiple Retailers

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    October 29, 2025

  2. Reported by FDA DEVICE

    December 3, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

This extension set attaches to gravity IV administration lines and to pump administration sets in hospital settings. It is part of standard IV therapy equipment used by clinicians to deliver medications and fluids.

Why This Is Dangerous

A backflow from piggyback containers into the primary IV line can occur and the system may fail to prime properly, risking incorrect dosing.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals may need to remove affected extension sets from inventory and replace them. The recall could disrupt IV therapy in some care settings.

Practical Guidance

How to identify if yours is affected

  1. Check packaging for AS152V2DLL label
  2. Verify Catalog Number 473309
  3. Confirm Primary UDI-DI 04046964299636
  4. Confirm Unit of Dose UDI-DI 04046964299629

Where to find product info

Serial numbers, date codes, and UPCs will appear on product labels and packaging as listed above

What timeline to expect

4-8 weeks for recall processing, depending on stock and logistics

If the manufacturer is unresponsive

  • File a consumer complaint with the FDA
  • Document all communications with the manufacturer
  • Seek assistance from hospital infection control or procurement if needed

How to prevent similar issues

  • Confirm device compatibility before purchasing IV extension sets
  • Check recalls and discontinue use promptly
  • Work with procurement to remove recalled lots from inventory

Documentation advice

Keep recall letter, take photos of product labels, save order receipts, and log all communications with manufacturer

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Product Details

Model numbers: AS152V2DLL; Catalog Number: 473309. Primary UDI-DI: 04046964299636. Unit of Dose UDI-DI: 04046964299629. Sold worldwide to US distribution and international markets including Canada, Germany, Guatemala, and Singapore. Sold date: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 11,650 units recalled worldwide
  • AS152V2DLL
  • Unit of Dose UDI-DI 04046964299629
  • Hazard: backflow and occlusion risk","Distribution: US and international markets (Canada, Germany,Gu

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 Classification

Product Details

Model Numbers
AS152V2DLL
473309
Report Date
December 3, 2025
Recall Status
ACTIVE

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