The Recall Desk
HighFDA (Devices)·Z-1543-2021·Announced 2021-05-19

Step-Har Medical Recalls Alaris Pump Modules with Impacted Bezel Repair Parts

Step-Har Medical is recalling two Alaris Pump Modules serviced with non-original bezel repair parts that may crack or separate, potentially causing infusion errors.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that can lead to infusion errors (over/under infusion), which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Step-Har Medical LLC is recalling two Alaris Pump Modules, Model 8100, that were serviced or repaired using bezel repair parts not made by the original manufacturer. The affected units have serial numbers 12747983 and 9919591 and were distributed in Iowa.

The recall is due to a risk that the bezel repair parts may crack or have their posts separate from the bezel over time. If this separation occurs, it may result in free flow, over-infusion, under-infusion, or interruption of the infusion.

Healthcare providers and facilities that have these specific serial numbers should stop using the affected pump modules and contact Step-Har Medical for instructions on repair or replacement.

The recalled product

Product
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Manufacturer
STEP-HAR MEDICAL LLC
Category
Medical Device — Infusion Pumps
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers: 12747983 and 9919591

Distribution

Distributed in 1 state:

Related recalls

Same hazard · infusion error

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