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
- 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
- B. Braun Medical
- Product type
- IV administration set
- Model numbers
- Catalog Number 354213, Primary UDI-DI 04046964182211, Unit of Dose UDI-DI 04046964182204
- Sold at
- Multiple Retailers
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
Outlook IV Sets are used in gravity IV administration and pump systems to deliver IV medications in hospital settings. They are associated with BBMI pumps including Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
Why This Is Dangerous
Backflow from secondary to primary IV containers and occlusion can lead to incorrect dosing or interruption of IV therapy.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to quarantine affected sets and implement immediate removal to prevent dosing errors and therapy delays.
Practical Guidance
How to identify if yours is affected
- Check catalog number 354213 on the device or packaging.
- Check Primary UDI-DI 04046964182211 and Unit of Dose UDI-DI 04046964182204.
- Confirm expiration date is the earliest expiry of comp or within 36 months.
Where to find product info
Identifiers are labeled on the product packaging and documentation. FDA recall page lists recall Z-0707-2026.
What timeline to expect
Replacement or recall processing typically takes 4-6 weeks after confirmation.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer, escalate to hospital risk management, contact FDA for guidance on recalls.
- Consider filing a complaint with regulatory authorities if the company is unresponsive.
How to prevent similar issues
- Verify UDI-DI labels before acquiring IV sets.
- Maintain a record of recall notices from the regulatory database.
- Establish a recall review process in healthcare procurement to rapidly identify affected lots.
Documentation advice
Keep the recall notice, take photos of catalog numbers and labels, save all correspondence, and track refunds or replacements.
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Product Details
Catalog Number: 354213. Primary UDI-DI: 04046964182211. Unit of Dose UDI-DI: 04046964182204. Expiration Date: Earliest Exp of Comp or 36mths. Sold worldwide including US, Canada, Germany, Guatemala and Singapore. Quantity: 18,072 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Unit of Dose UDI-DI 04046964182204
- Expiration Date: Earliest Exp of Comp or 36 months
- Distributed worldwide: US, Canada, Germany, Guatemala, Singapore`,`Hazard: backflow and occlusion`,`
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Safety Guide
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