Class I Recall: More Alaris Infusion Pumps Yanked From Market
Executive Summary
The US FDA has labeled the recall of nearly 2,500 Alaris Model 8100 infusion pumps as high-risk class I.
You may also be interested in...
BD Expects Alaris Infusion Pump To Return To US Market Next Year
The company stopped shipping Alaris in early 2020 after the FDA requested a new 510(k) for modifications and the device has been the subject of several recalls since then.
Class I Recall Of Alaris Device Is Pump’s Second In 3 Days
Third-party servicer Tenacore LLC recalled the Model 8100 infusion pumps because patients are at risk of receiving incorrect fluid dosage. The recall was designated as class I by the US FDA on 19 April; it’s the pump’s second class I recall in the span of three days.
US FDA: Recall Of BD Alaris Infusion Pump Is High-Risk Class I
Becton Dickinson’s CareFusion 303 Inc. subsidiary recalled 145,492 of the pumps because there’s a risk that the device’s keypad will lift up and away from the device body if it comes into contact with fluids.