Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Alaris Infusion Pump Module Recalled by Tenacore LLC Due to Bezel repair parts used, not by the original...

Date: February 25, 2021
Company: Tenacore LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tenacore LLC directly.

Affected Products

Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part

Quantity: 474

Why Was This 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.

Where Was This Sold?

This product was distributed to 16 states: AZ, CA, DE, FL, KY, LA, ME, MN, MO, NV, NY, NC, PA, TN, TX, WA

Affected (16 states)Not affected

About Tenacore LLC

Tenacore LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report