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

Class I - Dangerous

What Should You Do?

Check if you have this product:
Serial Numbers: 12747983 and 9919591
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Company:: STEP-HAR MEDICAL LLC
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

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

Serial Numbers: 12747983 and 9919591

Distributed in: IA

Always verify recall information with the official FDA source:

FDA Recall Number: Z-1543-2021