Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Assembly Defect
Covidien LLC is recalling 278 units of the Puritan Bennett 980 Series Ventilator due to a manufacturing defect that may cause the device to become inoperable during clinical use.
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 score of 4 per regulatory standards. No illnesses or injuries have been reported in connection with this manufacturing defect, which prevents escalation to Critical status.
Plain-English summary
Covidien LLC is recalling the Puritan Bennett 980 Series Ventilator, model 980X1ENDIUU. The recall affects 278 units distributed worldwide, including throughout the United States.
A manufacturing assembly error resulted in incorrect assembly of a capacitor within the ventilator. This defect may cause the device to become inoperable during clinical use.
Affected units are identified by specific serial numbers that have been provided by the manufacturer to the FDA. Hospitals and medical facilities in possession of affected units should verify their equipment against the manufacturer's list of involved serial numbers.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Ventilator
- 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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