Z-1543-2021Class I

Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part

Name: Z-1543-2021 Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Creator: Step-Har Medical Llc
Published: 2021-02-26
License: https://open.fda.gov/license/

Step-Har Medical LLC / initiated 2021-02-26 / Terminated / root cause: design

FDA source

STEP-HAR MEDICAL LLC began a recall of Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part on 2021-02-26. FDA classified it as Class I and 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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1543-2021
Classification: Class I
Status: Terminated
Initiated: 2021-02-26
Posted: 2021-05-10
Terminated: 2024-08-15
Recalling firm: Step-Har Medical LLC
Product: Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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 [email protected]
Quantity in commerce: 2
Distribution: IA
Product codes and lots: Serial Numbers: 12747983 and 9919591

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1543-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1543-2021	Class I	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-10

Product code FRN

K133532Class IIAlaris System with Guardrails Suite MxCarefusion 303, Inc. / cleared 2014-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)