CLASS I Device recall · Reported 19 May 2021 · FDA Enforcement Report
Alaris Pump Module recalled by Step-har Medical
Step-har Medical is recalling Alaris Pump Module, distributed in Iowa. The recall was initiated on 26 Feb 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1543-2021
- FDA event ID
- 87773
- Recalling firm
- Step-har Medical, Fountain Valley, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 26 Feb 2021
- FDA classified
- 10 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 26 Feb 2021 | Recall initiated by company | |
| 10 May 2021 | Classified by FDA | +73 days |
| 19 May 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Where it was distributed
IA
Questions about this recall
Is Alaris Pump Module recalled?
Yes. Step-har Medical recalled Alaris Pump Module on 26 Feb 2021. The recall is Class I and its status is Terminated. Recall number Z-1543-2021.
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 12747983 and 9919591
Where was it sold?
IA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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