B Braun Medical Inc recalls SafeDAY set utilized in gravity IV administration sets and pump administration sets utiliz
- Recalling company
- B Braun Medical Inc
- Product
- 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 ADMIN SET 60 DROP W/2 SAFEDAY; Catalog Number: 352635.
- Reason
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 29, 2025
- Reported
- Dec 3, 2025
- Distribution
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- Status
- Ongoing
- Quantity
- 200,917 units
- Lot / codes
- 1. Catalog Number: 352635; Primary UDI-DI: 04046955594948; Unit of Dose UDI-DI: 04046955594931; Expiration Date: 36mths from Start Date.
- Company location
- Bethlehem, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0711-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0711-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.