FDA Enforcement
Class I
Ongoing
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Recall: Z-2972-2024
·
Reported September 18, 2024
Enforcement
- Recall Number
- Z-2972-2024
- Event ID
- 95093
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B Braun Medical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- September 18, 2024
- Initiation Date
- August 7, 2024
- Classification Date
- September 6, 2024
- Address
- 200 Boulder Dr, Breinigsville, PA, 18031-1532, United States
Description
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
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 Info
UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337
Distribution
US distribution to AL, CA, GA, IL, MI, and TX.
Quantity
14