Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly Recalled by B. Braun Medical, Inc. Due to Firm became aware of the potential for breakage...

Date: March 23, 2012
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(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

Quantity: 38,225 pumps

Why Was This Recalled?

Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of t

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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