Home » FDA Says Covidien’s PB980 Ventilator Recall is Class 1
FDA Says Covidien’s PB980 Ventilator Recall is Class 1
The FDA has issued on update on Covidien’s Nov. 4 recall of its Puritan Bennett 980 (PB980) ventilator series system, deeming it a Class 1 recall because of the risk of serious injury or death.
The recall by the Medtronic subsidiary was prompted by incorrect assembly of a component on the printed circuit board, which may cause the device to become inoperable during use.
Users were advised to remove the affected ventilators from service and quarantine them pending a replacement of the printed circuit board assembly by the company.
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