FDA MedWatch – Tenacore’s Replacement of CareFusion Alaris 8100 Infusion Pump Module by Tenacore:

TOPIC: Tenacore’s Replacement of CareFusion Alaris 8100 Infusion Pump Module by Tenacore: Recall – Due to Potentially Weakened Plastic

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: On February 24th, 2021, Tenacore initiated a nationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. 

For more information about this recall and product details, click on the red button “Read Recall” below.

BACKGROUND: A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion.

RECOMMENDATIONS: 

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.