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Manufacturing Error Leads To Class I Recall For Covidien Ventilator

 
• By Elizabeth Orr

The US FDA says a problem with how a capacitor was installed in the devices is why almost 300 devices are being recalled.

The screen of a Puritan Bennett 980 ventilator is seen in this file photo.
Medtronic

Medtronic plc subsidiary Covidien plc. is recalling some batches of the Puritan Bennett 980 series ventilator over a manufacturing error, a recent notice from the US Food and Drug Administration states. The agency classified it as a class I recall, which means it carries the highest risk for patients.

According to the FDA, a capacitor within the ventilator was put together incorrectly, which could cause the device to suddenly become inoperable

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