⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

B Braun Medical Inc: ADDitIV utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outl

Medical DevicesSource: FDA (device) · Date: 2025-12-03

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Get alerts for B Braun Medical

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
B Braun Medical Inc
Product
ADDitIV 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. PB602VSL NON-VENT SET 103-IN-DR; Catalog Number: 352062.
Reason / hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Recall initiated
2025-10-29
Code info
1. Catalog Number: 352062; Primary UDI-DI: 04046964181160; Unit of Use UDI-DI: 04046964181153.
Product quantity
12,700 units
Voluntary mandated
Voluntary: Firm initiated
City
Bethlehem
State
PA
Country
United States
Event id
97816
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.