HIGH

B Braun Medical IV Administration Sets Recalled Over Backflow and Occlusion Risk (2025)

B Braun Medical Inc. recalls 168,816 IV administration sets worldwide, including US and international distributors. The recall targets gravity and pump administration sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The issue is potential backflow from piggyback containers into primary IV containers and inability to prime.

Quick Facts at a Glance

Recall Date
October 29, 2025
Hazard Level
HIGH
Brand
B Braun Medical
Category
Health & Personal Care
At-Risk Groups
GENERAL, PREGNANT, ELDERLY

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 enable medication delivery via gravity or infusion pumps. They connect IV bags to patient lines and may include secondary piggyback features for multiple meds.

Why This Is Dangerous

Backflow from piggyback containers into the primary line can occur if the set fails to prime properly, potentially delivering unintended doses or reducing flow.

Industry Context

This recall is not part of a broader industry pattern mentioned in the data.

Real-World Impact

Healthcare facilities may need to replace affected sets to prevent dosing errors and interruptions in therapy.

Practical Guidance

How to identify if yours is affected

  1. Check catalog numbers on the packaging: 490385 and 490401.
  2. Cross-check with Primary UDI-DI 04046964730146 or 04046964761416.
  3. Verify Unit of Dose UDIs: 04046964730139 or 04046964761409.
  4. If in doubt, contact BBMI for confirmation.

Where to find product info

UDI codes and catalog numbers are typically printed on the product packaging and accompanying documentation.

What timeline to expect

Remedies are subject to manufacturer timing; expect several weeks for replacement or refund.

If the manufacturer is unresponsive

  • Document all communication attempts.
  • File a formal complaint with the FDA if necessary.
  • Consult healthcare facility compliance teams for guidance.

How to prevent similar issues

  • When purchasing IV sets, verify UDI and catalog numbers against recall notices.
  • Choose sets with verified priming and backflow prevention features.
  • Maintain a ready list of covered BBMI products for quick validation.

Documentation advice

Keep purchase receipts, packaging, recall notices, and all correspondence. Photograph catalogs, UDIs, and lot numbers.

Product Details

IV Administration Sets with catalog numbers 490385 and 490401. Catalog 490385: 10 drops/ml, 144 inches. Primary UDI-DI 04046964730146; Unit of Dose UDI-DI 04046964730139. Catalog 490401: 3 CARESITES, 120 inches. Primary UDI-DI 04046964761416; Unit of Dose UDI-DI 04046964761409. Distributed worldwide, including US, Canada, Germany, Guatemala, Singapore.

Reported Incidents

No injuries or incidents have been reported in the recall notice. The hazard is identified by the FDA enforcement notice.

Key Facts

  • 168,816 total units recalled
  • Catalog 490385 and 490401
  • Catalog 490385: 10 drops/ml, 144 in
  • Catalog 490401: 3 CARESITES, 120 in
  • Primary UDI-DI 04046964730146 (490385)
  • Unit of Dose UDI-DI 04046964730139 (490385)

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
GENERALPREGNANTELDERLYPREGNANTPETS
Injury Types
ELECTRICALPOISONINGSUFFOCATION

Product Details

Model Numbers
Catalog Number: 490385
Primary UDI-DI: 04046964730146
Unit of Dose UDI-DI: 04046964730139
Catalog Number: 490401
Primary UDI-DI: 04046964761416
+1 more
Report Date
December 3, 2025
Recall Status
ACTIVE

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