FDA recall Z-2972-2024

Product

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

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

Key facts

Status

Ongoing

Initiation date

2024-08-07

Report date

2024-09-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Breinigsville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2972-2024