FDAFDA · Food and drugs·Recall number Z-0712-2026
SafeDAY 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 ADM SET 15 DR W/2 SAFEDAY & STOPCOCK; Catalog Number: 352646.
Published December 3, 2025 · Recall initiated: October 29, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B Braun Medical Inc
- Distributor
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- Lot
- 1. Catalog Number: 352646; Primary UDI-DI: 04046955626946; Unit of Dose UDI-DI: 04046955626939; Expiration Date: 36mths from Start Date.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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