Event Title Go back to Home Page
Event Summary  
Event Type Medicine - Medical Products Or Devices
Medicine - Pharmaceutical Recalls 
Date Time 2021-04-19 20:54:00 
Country US  City Santa Ana, CA 
Latitude 33.745  Longitude -117.868 
URL https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tenacore-llc-issues-nationwide-recall-tenacores-replacement-front-bezel-assembly-carefusion-alaris     
[fda.gov] CALIFORNIA - Tenacore LLC Issues Nationwide Recall of Tenacore’s Replacement for the Front Bezel Assembly of the CareFusion Alaris 8100 Infusion Pump Module

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

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