Alaris Pump Module (Step-Har Medical) – Bezel Repair Risks (2021)
Non-original bezel repair parts can potentially cause infusion pump module malfunction.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Brand
STEP-HAR MEDICAL LLC
Lot Codes / Batch Numbers
Serial Numbers: 12747983 and 9919591
Products Sold
Serial Numbers: 12747983 and 9919591
STEP-HAR MEDICAL LLC is recalling Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair due to Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separatio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 02/26/2021, the one customer was notified of the recall via phone call and email. On 04/15/21, a Voluntary Field Safety Corrective Action notice were mailed. The firm asked their customer to respond so the bezel repair part could be replaced. Customers can contact the recalling firm at: 657-267-0054 or stdoan@stepharmedical.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IA
Page updated: Jan 10, 2026