HIGH

B Braun Medical Recalls IV Administration Set Due to Backflow Risk

B Braun Medical recalled 2,100 IV administration sets on October 29, 2025. The recall follows reports of backflow of medication from secondary IV containers into primary IV containers. This poses a high risk for patients using the Infusomat Space, Outlook, and Vista pumps.

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

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recalled product includes the extension set labeled as ANES SET W/DUAL FEM.LL SAFEPORT MANIFOLD, Catalog Number: 456520. The product was distributed worldwide, including the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The extension set poses a high risk of backflow, potentially allowing medication from secondary IV containers to contaminate primary IV containers. This can lead to incorrect medication administration and patient harm.

Reported Incidents

There have been no specific reported incidents or injuries associated with this recall. However, the potential for serious health risks exists due to the nature of the hazard.

What to Do

Stop using the recalled IV administration sets immediately. Follow the recall instructions provided by your healthcare provider or contact B Braun Medical Inc for further guidance.

Contact Information

For more information, contact B Braun Medical at 1-800-854-6851 or visit their website at www.bbraun.com.

Key Facts

  • Recall date: October 29, 2025
  • Quantity recalled: 2,100 units
  • Distribution: Worldwide, including US and Canada
  • Hazard classification: Class II

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeIV Administration Set
Sold At
Multiple Retailers

Product Details

Model Numbers
1. Catalog Number: 456520
Primary UDI-DI: 04046964296697
Unit of Dose UDI-DI: 04046964296680.
Report Date
December 3, 2025
Recall Status
ACTIVE

Related Recalls

HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
Read more