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 Recalled by STEP-HAR MEDICAL LLC Due to Bezel repair parts used, not by the original...

Date: February 26, 2021
Company: STEP-HAR MEDICAL LLC
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 STEP-HAR MEDICAL LLC directly.

Affected Products

Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part

Quantity: 2

Why Was This Recalled?

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

Where Was This Sold?

This product was distributed to 1 state: IA

Affected (1 state)Not affected

About STEP-HAR MEDICAL LLC

STEP-HAR MEDICAL LLC has 1 total recall tracked by RecallDetector.

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