B Braun Medical IV Set Recall Affects 32,436 Units Over Backflow and Occlusion Risks (2025)
B Braun Medical Inc. recalled 32,436 Anesthesia IV Sets used with Infusomat Space, Outlook Pump, and Vista Basic Pump after reports of backflow risk and occlusion. The recall covers catalog numbers 490189 and 490226 distributed worldwide, including the US, Canada, Germany, Guatemala and Singapore. Consumers should stop using the device immediately and follow manufacturer instructions for recall. A
About This Product
These IV sets are used to deliver medications through gravity or pump-assisted IV systems in clinical settings.
Why This Is Dangerous
Backflow can allow medication from a piggyback container to flow into the primary container, potentially delivering a higher concentration or contamination. Occlusion can prevent proper priming of the line, disrupting flow.
Industry Context
This recall is not described as part of a broader pattern in the data.
Real-World Impact
Healthcare facilities may need to halt use of affected IV sets, potentially disrupting workflows and requiring replacements.
Practical Guidance
How to identify if yours is affected
- Check catalog numbers 490189 and 490226.
- Verify Primary UDI-DI 04046964303586 for 490189 and 04046964304262 for 490226.
- Check Unit of Use UDI-DI 04046964303579 for 490189 and 04046964304255 for 490226.
Where to find product info
UDI codes are printed on the packaging and on device labels.
What timeline to expect
Remedy delivery and replacement timelines not specified; expect recall follow-up communications.
If the manufacturer is unresponsive
- Document your contact attempts
- Escalate to hospital risk management or distributor
- Reach out to FDA or local health authority if unresolved
How to prevent similar issues
- Verify device compatibility with pumps before use
- Maintain an up-to-date device inventory with UDI codes
- Follow manufacturer recall communications promptly
- Establish a recall response protocol for clinical settings
Documentation advice
Keep recall notice, shipment receipts, and correspondence with manufacturer and healthcare providers.
Product Details
Brand: B Braun Medical. Product: Anesthesia IV Set used with gravity and pump administration sets. Catalog numbers: 490189 (IV ADMIN SET W/15 DROPS/ML, 108 IN) and 490226 (IV ADMIN SET 137 IN). Primary UDI-DI: 04046964303586 (490189) with Unit of Use 04046964303579; Primary UDI-DI: 04046964304262 (490226) with Unit of Use 04046964304255. Sold worldwide with US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Recall date: 2025-10-29. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.