B. Braun Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0123-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

Product Classification:

Class I

Date Initiated: September 21, 2023

Date Posted: November 1, 2023

Recall Number: Z-0123-2024

Event ID: 92978

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.

Status: Ongoing

Product Quantity: 9771

Code Information:

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

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated