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.
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The US FDA has labeled the recall of nearly 2,500 Alaris Model 8100 infusion pumps as 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.
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.