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.

Alaris Pump Module Model 8100 Recalled by CareFusion 303, Inc. Due to Broken elements on pump module platen such as...

Date: June 30, 2020
Company: CareFusion 303, 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 CareFusion 303, Inc. directly.

Affected Products

Alaris Pump Module Model 8100

Quantity: 1093588

Why Was This Recalled?

Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (50 states)Not affected

About CareFusion 303, Inc.

CareFusion 303, Inc. has 163 total recalls tracked by RecallDetector.

Related Recalls

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