Class I

Medical Device Recall: Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U

B Braun Medical Inc · August 7, 2024

Reason for Recall

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.

Distribution

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

States Affected

AL, CA, GA, IL, MI, TX

Quantity Affected

14

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2972-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.