B. Braun Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0124-2024)

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:

8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System

Product Classification:

Class I

Date Initiated: September 21, 2023

Date Posted: November 1, 2023

Recall Number: Z-0124-2024

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: 884

Code Information:

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

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated