Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- BB Braun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BB Braun Medical
- Product type
- Extension Set for IV administration (gravity and pump) with BBraun Infusomat Space Outlook Vista Pumps
- Model numbers
- Catalog Number: 456521, Primary UDI-DI: 04046964296710, Unit of Dose UDI-DI: 04046964296703, Catalog Number: 456522, Primary UDI-DI: 04046964296734, Unit of Dose UDI-DI: 04046964296727
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 29, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
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 is used to connect IV medication containers to a patient via gravity or electronic infusion pumps. It is common in hospital settings for delivering continuous medications.
Why This Is Dangerous
Backflow from secondary IV containers into primary lines could cause incorrect dosing or contamination. Inability to prime increases infusion risk.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Healthcare facilities may need to halt use while replacements are sourced, potentially affecting workflow and medication administration.
Practical Guidance
How to identify if yours is affected
- Locate catalog numbers 456521 or 456522 on the extension set packaging or documentation.
- Verify device is connected to Infusomat Space, Outlook, or Vista Basic pumps.
Where to find product info
Manufacturer recall communications and FDA enforcement page Z-0637-2026.
What timeline to expect
Facilities should expect shipments of replacement or remediation guidance within weeks to a few months depending on supply chain.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Document attempts and seek alternate suppliers
- File a complaint with CPSC if consumer-grade units are affected
How to prevent similar issues
- Implement a double-check of circuit connections during IV setup
- Establish a standard operating procedure for IV extension sets compatibility with pumps
- Keep a log of recall-related replacements
Documentation advice
Retain recall notice, communications with supplier, purchase records, and photos of affected units and UDIs.
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Product Details
Extension Set for gravity IV administration and pump administration used with BBraun Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump. Catalog numbers 456521 and 456522. Primary UDI-DI 04046964296710 and 04046964296734 for the two catalogs. Unit of dose UDI-DI 04046964296703 and 04046964296727. 61,423 units distributed worldwide, including US, Canada, Germany, Guatemala, and Singapore. Recall Date: 2025-10-29. Status: ACTIVE.
Reported Incidents
No incidents or injuries are detailed in the provided recall information. No other incident counts are listed.
Key Facts
- Catalog numbers 456521 and 456522
- Global distribution: US, Canada, Germany, Guatemala, Singapore
- Hazard: backflow between IV lines and occlusion
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Safety Guide
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