Z-2972-2024 Class I Ongoing
FDA device recall Z-2972-2024 was initiated by B Braun Medical Inc on August 7, 2024 and is designated Class I. 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 downstr… The recall status is ongoing. Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- August 7, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
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 Pattern
US distribution to AL, CA, GA, IL, MI, and TX.
Code Information
UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337