Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Infusomat Space Volumetric Pump Administration Set Recalled by B. Braun Medical, Inc. Due to There is a potential for the Anti-free flow...

Date: June 25, 2021
Company: B. Braun Medical, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact B. Braun Medical, Inc. directly.

Affected Products

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Quantity: 36,144 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 4 states: CA, MI, OR, UT

Affected (4 states)Not affected

About B. Braun Medical, Inc.

B. Braun Medical, Inc. has 216 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report