Product Wiki · Recalls · U.S. FDA — Device Enforcement

IV Administration 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. IV SET W/2 CARESITE & 1 ULTRAPORT ZERO; ULTRAPO — recall Z-0646-2026

U.S. FDA — Device Enforcement · United States · 2025-10-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0646-2026
Date of alert
2025-10-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
B Braun Medical Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04046964716126
Reported risk: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.