B. Braun Medical, Inc.: 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

Hazard

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.

Details from the source

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. Quantity: 884 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

UPC codes

04046964708626

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.