Class I Recall: More Alaris Infusion Pumps Yanked From Market
The US FDA has labeled the recall of nearly 2,500 Alaris Model 8100 infusion pumps as high-risk class I.
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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.
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.
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.