B. Braun Medical, Inc.: 8713051U, Infusomat Large Volume Pump, Wireless; 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: 9771 Lot/code info: UDI-DI: 04046964660887 Serial Numbers: 868497 -892669 ***Updated 8/7/24*** SNs added: 430056, 430119, 430155, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, 814074

UPC codes

04046964660887

Source

Official record: FDA (Device enforcement) ↗

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