FDA recall Z-0070-2026

B BRAUN MEDICAL INC · Class I · device

Product

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

Reason for recall

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

Distribution

Domestic: US Nationwide Distribution.

Key facts

Status: Ongoing
Initiation date: 2025-09-30
Report date: 2025-10-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2026