B Braun Medical Inc recalls Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U

Recall date

August 7, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2972-2024

FDA classification

Class I

Brand / firm

B Braun Medical Inc

Sold / distributed

US distribution to AL, CA, GA, IL, MI, and TX.

Why it was recalled

Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.

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

Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U