FDA recall Z-0124-2024

B. Braun Medical, Inc. · Class I · device

Product

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

Reason for recall

Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

Distribution

Domestic distribution nationwide. Foreign distribution to Canada.

Key facts

Status
Ongoing
Initiation date
2023-09-21
Report date
2023-11-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0124-2024