HIGH

B Braun Medical Recalls IV Administration Sets Over Backflow Risk

B Braun Medical recalled 46,250 IV administration sets on October 29, 2025. The recall follows concerns about potential backflow of medication into primary IV containers. The affected products were sold worldwide, including the US and Canada.

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 recall affects several models: UNIVERSAL IV ADMIN SET (Catalog Number: 352604), SAFELINE ADDITIVE (Catalog Number: NF1251), and SAFELINE PED. ADDITIVE (Catalog Number: NF1290). These sets were distributed internationally, including in the US, Canada, Germany, Guatemala, and Singapore.

The Hazard

The recalled IV sets pose a high risk due to potential backflow of medication from secondary IV containers. This could lead to unintended drug administration and patient safety concerns.

Reported Incidents

There have been no specific incidents reported related to this recall. However, the nature of the hazard raises serious concerns about patient safety.

What to Do

Healthcare providers and patients should stop using the affected IV sets immediately. Contact B Braun Medical for instructions on the recall process.

Contact Information

For more information, call B Braun Medical at 1-800-xxx-xxxx or visit their website at www.braun.com.

Key Facts

  • 46,250 units recalled
  • Risk of backflow of medication
  • Affected models include catalog numbers 352604, NF1251, NF1290
  • Recall initiated on October 29, 2025
  • Sold worldwide including US and Canada

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: 352604
Primary UDI-DI: 04046964181870
Unit of Dose UDI-DI: 04046964181863
Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: NF1251
Primary UDI-DI: 04046964187100
+5 more
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