HIGH

BBMI IV Administration Sets Recalled in 2025 for Backflow and Occlusion Risk, 20.7 Million Units

BBMI Medical recalled 20,694,734 IV administration sets due to backflow risk and occlusion in piggyback configurations. The recall covers sets used with Infusomat Space, Outlook, and Vista Basic Pumps. Stop using the devices immediately and follow manufacturer instructions.

Quick Facts at a Glance

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

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 connect IV bags to patients. These are used in gravity and pump-assisted administration.

Why This Is Dangerous

Backflow can cause medication contamination or incorrect dosing. Occlusion can prevent proper flow of IV fluids.

Industry Context

This recall is not explicitly described as part of a broader industry pattern in the data.

Real-World Impact

Large-scale recall affecting medical facilities. Potential disruption to IV therapy and device replacement timelines.

Practical Guidance

How to identify if yours is affected

  1. Review catalog numbers listed in recall
  2. Cross-check with supplier inventory and serials/UDI where available
  3. Consult facility risk management for remediation plan

Where to find product info

Recall notice and FDA page with recall number Z-0670-2026

What timeline to expect

Remediation timelines vary; replacement or refunds advised by BBMI

If the manufacturer is unresponsive

  • Escalate to hospital risk management
  • File complaint with FDA if supplier unresponsive
  • Consult legal counsel for prolonged non-compliance

How to prevent similar issues

  • Verify device compatibility before use
  • Maintain updated inventory of safe IV sets
  • Establish recall protocol with suppliers
  • Validate UDI numbers for tracing and recall response

Documentation advice

Document catalog numbers, quantities on hand, lot numbers, and correspondence with BBMI

Product Details

Brand: BBMI Medical. Product: IV Administration Sets. Tools: Used with Infusomat Space Large Volume Pump, Outlook Pump, Vista Basic Pump. Catalog numbers span 352636 to 490589 with 49 distinct items. Distribution: Worldwide; US and international (Canada, Germany, Guatemala, Singapore). Recall date: 2025-10-29. Report date: 2025-12-03.

Reported Incidents

No specific injuries or incidents are detailed in the provided data.

Key Facts

  • 20,694,734 units recalled
  • Catalog numbers range 352636 through 490689 approximately
  • Primary issues include backflow risk and occlusion risk
  • Global distribution including US, Canada, Germany, Guatemala, Singapore
  • Recall effective 2025-10-29; report 2025-12-03

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
GENERALPREGNANTPREGNANTINFANTSCHILDRENPETS
Injury Types
ELECTRICALLACERATIONPOISONINGSUFFOCATIONOTHER

Product Details

Model Numbers
352636
352639
352640
352643
477003
+45 more
Report Date
December 3, 2025
Recall Status
ACTIVE

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