Puritan Bennett 980 Series Ventilator Recall Due to Assembly Error
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a capacitor assembly error that may cause the device to become inoperable during use. Affected devices were distributed worldwide with specific serial numbers targeted.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as Severe because the FDA designated it as a Class I recall, which mandates a minimum severity score of 4 per the rubric. No deaths or serious injuries have been reported in the source text, preventing a Critical rating, but the Class I classification confirms the potential for serious patient harm.
Plain-English summary
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators (model 980X3JADIJJ) due to a manufacturing assembly error. A capacitor within the device was assembled incorrectly, which may cause the ventilator to become inoperable during use.
This is a Class I medical device recall, indicating potential for serious patient harm. The affected devices were distributed worldwide, including throughout the United States. The recall specifically targets 11 serial numbers ranging from 35B1700393 to 35B1800002.
Healthcare facilities and users with affected serial numbers should immediately discontinue use of the device and contact Covidien LLC for information regarding replacement or repair. The FDA has designated this as a Class I recall due to the potential for device failure during critical patient use.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
- Manufacturer
- Covidien Llc
- Hazard
- assembly-defect
- device-failure
Distribution
Distributed nationwide across the United States.
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