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.
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.
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.
The bezel repair parts used by Step-Har Medical may crack or separate from the pump module over time. This separation can cause the pump to over-infuse, under-infuse, or stop delivering medication entirely.
Users of Alaris Pump Module Model 8100 who had this unit serviced by Step-Har Medical are affected. Patients using these pumps for medical infusion therapy are at risk if the repair part fails.
Check if your Alaris Pump Module Model 8100 was serviced by Step-Har Medical. Affected units have serial numbers 12747983 and 9919591.
Verify if your pump has serial numbers 12747983 or 9919591.
The bezel repair parts used by Step-Har Medical may crack or separate over time, causing infusion interruptions like over-infusion or under-infusion.
Check if your Alaris Pump Module Model 8100 has serial numbers 12747983 or 9919591.
The recall does not require immediate stop use; affected units should be checked for serial numbers.
We’ve drafted a message you can send Step-Har Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1543-2021 — Step-Har Medical Step-Har Medical Hello, I own a Step-Har Medical that is covered by recall Z-1543-2021 from Step-Har Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
