B. Braun Medical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2137-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Product Classification:

Class II

Date Initiated: June 25, 2021

Date Posted: August 4, 2021

Recall Number: Z-2137-2021

Event ID: 88198

Reason for Recall:

There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

Status: Terminated

Product Quantity: 36,144 units

Code Information:

Lot Number: 0061761278

Distribution Pattern:

Affected products were distributed to the following US states: CA, MI, OR, and UT.

Voluntary or Mandated:

Voluntary: Firm initiated