The FDA announced on 2023-09-21 that B. Braun Medical, Inc. is recalling the Infusomat Large Volume Pump, Wireless (model 8713051U) due to a hazard that may be life-threatening or lead to death. The device's upstream occlusion alarm may sound falsely and stop pumping, interrupting high-risk medication infusions.
How to tell if you have it
- Brand: B. Braun
- Product: Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System
- Model/Part Number: 8713051U
- Serial Numbers: 868497 - 892669, plus 430056, 430119, 430155, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, 814074
- Distribution: Domestic nationwide and to Canada
The hazard
According to the FDA, the upstream occlusion alarm may sound when no occlusion exists, causing the device to stop pumping. This 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.
Context
GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since 2013-10-15. Other recent recalls of similar products include B. Braun Medical 100mL Sodium Chloride Injection Recall (2026-08-19), B. Braun Medical Lactated Ringer's Injection Recall (2026-08-12), and B Braun Discofix Four Way Stopcock Recall (2026-08-04). Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion Pump Recall (2025-11-03), Spectrum IQ Infusion Pump Recall (2026-01-13), and Fresenius Kabi Ivenix Infusion System Software Recall (2026-05-06).