Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SAFELINE set utilized in gravity IV administration sets and pump Recalled by B Braun Medical Inc Due to Potential for backflow of medication from secondary (piggyback)...

Date: October 29, 2025
Company: B Braun Medical Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact B Braun Medical Inc directly.

Affected Products

SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. UNIVERSAL IV ADMIN SET; Catalog Number: 352604. 2. SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1251. 3. SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1290.

Quantity: 46,250 units

Why Was This Recalled?

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Where Was This Sold?

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

About B Braun Medical Inc

B Braun Medical Inc has 148 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report