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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"
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
- 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:
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