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: 354214, Primary UDI-DI: 04046964182235, Unit of Dose UDI-DI: 04046964182228
- 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
The Outlook IV Set is used in gravity IV administration and pump-driven IV administration with BBMI pumps such as Infusomat Space, Outlook Pump, and Vista Basic Pump.
Why This Is Dangerous
A backflow risk exists when medication from secondary containers can re-enter the primary IV line. The device may be unable to prime, potentially interrupting therapy.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt use, replace affected sets, and review IV therapy workflows to avoid delays in treatment.
Practical Guidance
How to identify if yours is affected
- Check labeling for Catalog Number 354214 and model Outlook IV Set 15DR W/2 CARESITE FILTER.
- Verify Primary UDI-DI 04046964182235 and Unit of Dose UDI-DI 04046964182228.
- Confirm compatibility with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump.
Where to find product info
FDA recall page, manufacturer recall communications, and labeling on the device.
What timeline to expect
Recall processing timelines are not specified; expect notification by letter and replacement instructions to follow.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- If necessary, escalate to hospital procurement or file a consumer complaint with authorities
How to prevent similar issues
- Implement backflow-prevention checks in IV sets procurement
- Verify device compatibility with BBMI pumps before purchase
- Review suppliers' recall compliance processes
Documentation advice
Keep recall notices, purchase records, and correspondence; photograph product labeling and UDI codes for records
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Catalog Number: 354214; Model: Outlook IV Set 15DR W/2 CARESITE FILTER; Primary UDI-DI: 04046964182235; Unit of Dose UDI-DI: 04046964182228; Distribution: Worldwide (US distribution and international distribution to Canada, Germany, Guatemala, and Singapore). Expiration: Earliest Exp of Component or 36 months.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model: Outlook IV Set 15DR W/2 CARESITE FILTER
- Unit of Dose UDI-DI: 04046964182228
- Distribution: Worldwide (US and international incl. Canada, Germany, Guatemala, Singapore)
- Expiration: Earliest Exp of Component or 36 months
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.