Medical device recalls High risk

B BRAUN MEDICAL INC recalls Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M209…

Recall date
September 30, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0070-2026
FDA classification
Class I
Brand / firm
B BRAUN MEDICAL INC
Sold / distributed
Domestic: US Nationwide Distribution.

Why it was recalled

The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial and venous patient connectors.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG Component: N/A

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