Recall Z-0124-2024— B. Braun Medical, Inc.

Name: FDA recall Z-0124-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-21

Class I · Ongoing

Class I FDA medical device recall by B. Braun Medical, Inc., initiated 2023-09-21. It names 2 FDA 510(k) clearances: K191910, K142596. Product: 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System. Reason: 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..

Recalling firm: B. Braun Medical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-09-21
Firm location: Allentown, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K191910 — SpaceStation MRIB. Braun Melsugen AG·cleared 2020-03-12
K142596 — Infusomat Space Volumetric Infusion PumpB.Braun Medical, Inc.·cleared 2015-06-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.