Puritan Bennett 980 Series Ventilator Recalled for Assembly Defect
Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during 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: This recall is classified as Severe because the FDA designated it as a Class I recall, indicating a reasonable probability of serious adverse health consequences. No deaths or injuries have been reported to date; the severity is based on the potential for device malfunction during patient use.
Plain-English summary
Covidien Llc is recalling the Puritan Bennett 980 Series Ventilator (model 980A3ENNISB) due to a manufacturing defect. A capacitor within the ventilator was assembled incorrectly during manufacturing, which may cause the device to become inoperable during use.
Approximately 278 units have been distributed worldwide, including throughout the United States. Affected devices carry serial numbers 35B1700246, 35B1700543, and 35B1700887. The FDA classified this as a Class I recall due to the potential for device failure during use.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980A3ENNISB
- Manufacturer
- Covidien Llc
- Affected units
- 278
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- GTIN/UDI - 10884521201910 Serial Numbers: 35B1700246
- 35B1700543
- 35B1700887
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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