FDA-Device2026-04-22Class IPROCESSING DEFECT

B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.

OTHERNationwide distributionMedical devices
Hazard

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
1,174,271 units
Manufactured in
824 12th Ave, N/A, Bethlehem, PA, United States
Products
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1800-2026

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