B. Braun Medical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2401-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104

Product Classification:

Class II

Date Initiated: June 17, 2024

Date Posted: July 24, 2024

Recall Number: Z-2401-2024

Event ID: 94823

Reason for Recall:

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

Status: Ongoing

Product Quantity: 59811 units

Code Information:

UDI-DI 04046964186141; All Lots Distributed After 01AUG2023.

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated