Use caution Medical device recall · FDA · Published February 26, 2021

Step-Har Medical Alaris Pump Module 8100: Risk of Infusion Interruption

Step-Har Medical recalls Alaris Pump Module Model 8100 with impacted bezel repair parts that may cause infusion interruptions. Affected units have specific serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1543-2021Medical device Step-Har Medical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmSTEP-HAR MEDICAL LLC11237 Slater Ave · Fountain Valley, CA 92708-5417

✎ GovInfoNow plain-language explainer

Step-Har Medical is recalling Alaris Pump Module Model 8100 units that were serviced by their company with a specific bezel repair part. This repair part can crack or separate over time, potentially causing infusion interruptions like over-infusion or under-infusion. Read more at govinfonow.com/recall/63188-step-har-medical-alaris-pump-module-8100-risk-of-infusion.

Source Summary by GovInfoNow · govinfonow.com/recall/63188-step-har-medical-alaris-pump-module-8100-risk-of-infusion · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1543-2021

Cite this page

“Step-Har Medical Alaris Pump Module 8100: Risk of Infusion Interruption.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63188-step-har-medical-alaris-pump-module-8100-risk-of-infusion. Based on FDA recall #Z-1543-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1543-2021%22&limit=1).

The FDA announced on Feb. 26, 2021, that Step-Har Medical LLC voluntarily recalled two Alaris Pump Modules, Model 8100, due to potential infusion errors. The recall affects units serviced by the company with impacted bezel repair parts.

How to tell if you have it

Brand: Step-Har Medical
Product: Alaris Pump Module, Model 8100
Serial Numbers: 12747983 and 9919591
Quantity: 2 units
Distribution: Iowa

The hazard

According to the FDA, bezel repair parts used by Step-Har Medical may crack or separate over time. This separation can result in free flow, over infusion, under infusion, or interruption of infusion.

Context

GovInfoNow's records show other recent recalls of similar products include BD Alaris Pump Infusion Sets Recall (2026-08-19) and Fresenius Kabi LVP-0004 Infusion Pump Recall (2026-02-04). Additional similar product recalls include the Fresenius Kabi Ivenix Infusion Pump Recall dated 2025-11-03.

How to tell if you have this one

Check if your Alaris Pump Module Model 8100 was serviced by Step-Har Medical. Affected units have serial numbers 12747983 and 9919591.

Brand
Step-Har Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify if your pump has serial numbers 12747983 or 9919591.

Where it went and when

Where it was distributed

Distributed in Iowa.

FDA distribution: “IA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Iowa.

Recall timeline

FDA terminated this recall 3.5 years after the firm started it.

Feb 26, 2021Firm started the recall
May 10, 2021FDA classified it Class I
May 19, 2021Published in FDA’s Enforcement Report
Aug 15, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the pump immediately?

The recall does not require immediate stop use; affected units should be checked for serial numbers.

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Link to this recall

<a href="https://govinfonow.com/recall/63188-step-har-medical-alaris-pump-module-8100-risk-of-infusion">Step-Har Medical Alaris Pump Module 8100: Risk of Infusion Interruption (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1543-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1543-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.