Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2972-2024

August 07, 2024

Class I

Product summary

Firm
B Braun Medical Inc
Event
Event 95093
Status
Ongoing
Classification
Class I
Quantity
14
Official record key
device-enforcement:Z-2972-2024

Official wording

Reason: 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.

Code information: UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.