STEP-HAR MEDICAL LLC: Medical Device Recall in 2021 - (Recall #: Z-1543-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: February 26, 2021

Date Posted: May 19, 2021

Recall Number: Z-1543-2021

Event ID: 87773

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.

Status: Terminated

Product Quantity: 2

Code Information:

Serial Numbers: 12747983 and 9919591

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated