medical Class I Updated 2023-11-01

B. Braun Medical, Inc. recalls 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04046964708626 Serial Numbers: 878498 -881897 ***Update 8/7/24*** Additional SNs 133238, 133975, 490442, 546815, 559325, 561645, 562713, 593049, 617405, 617409, 618522, 783680, 810031
View official government recall

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