Puritan Bennett 980 Ventilators Recalled Due to Manufacturing Assembly Error
Covidien is recalling Puritan Bennett 980 Series Ventilators (model 980X1ENAIQC) due to an incorrectly assembled capacitor that may cause the device to become inoperable. The recall involves 278 units distributed worldwide, including the US.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use."
Plain-English summary
Covidien Llc is recalling the Puritan Bennett 980 Series Ventilator, model 980X1ENAIQC, due to a manufacturing assembly error. A capacitor was assembled incorrectly, which may cause the ventilator to become inoperable during use.
The recall affects 278 units distributed worldwide, including throughout the United States. Affected devices can be identified by serial number 35B1703376 and GTIN/UDI 10884521171787.
This is a Class I FDA recall, indicating a serious health hazard. The recalled ventilators are used as life-support equipment in healthcare settings.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator,980X1ENAIQC
- 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 (1)
- GTIN/UDI - 10884521171787 Serial Numbers: 35B1703376
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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