FDA-Device2025-12-03Class IIPROCESSING DEFECT
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. Catalog Number: 490549; Primary UDI-DI: 04046955270323; Unit of Dose UDI-DI: 04046955270316; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490565; Primary UDI-DI: 04046955275601; Unit of Dose UDI-DI: 04046955275595; Expir
OTHERNationwide distribution
Hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Sold states
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Affected count
65,232 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
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. Catalog Number: 490549; Primary UDI-DI: 04046955270323; Unit of Dose UDI-DI: 04046955270316; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490565; Primary UDI-DI: 04046955275601; Unit of Dose UDI-DI: 04046955275595; Expiration Date: Earliest Exp of Comp or 36mths.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0675-2026More B Braun Medical Inc recalls
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- FDA-Device2026-04-22B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
- FDA-Device2026-04-22B Braun hemodialysis bloodlines recalled for potential air bubble accumulation in arterial line
- FDA-Device2026-04-22B. Braun hemodialysis bloodlines recalled for potential air bubble accumulation
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