Reported May 19, 2021 · Terminated

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

Step-Har Medical LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: STEP-HAR MEDICAL LLC · 11237 Slater Ave · Fountain Valley, CA · 92708-5417

Is this the product you have?

  • Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Lot codes and dates
  • Serial Numbers12747983 and 9919591
Amount recalled
2

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 15, 2024 · Data as of Sep 19, 4:58 PM UTC

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