Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error
Puritan Bennett 980 Series Ventilators are recalled due to an assembly error in a capacitor that may cause the device to become inoperable during use. The recall affects 278 units.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of Severe. The manufacturing defect in a critical medical device that may become inoperable during use justifies this classification.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class I recall for the Puritan Bennett 980 Series Ventilator, model 980U1ENASAA, manufactured by Covidien Llc. A total of 278 units are subject to this recall.
The recall is due to a manufacturing assembly error. A capacitor within the ventilator was assembled incorrectly. This error may cause the device to become inoperable during use.
The affected units have been distributed worldwide, including throughout the United States. The affected units can be identified by their serial numbers, which are detailed in the official recall notice.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980U1ENASAA
- Manufacturer
- Covidien Llc
- Affected units
- 278
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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