Puritan Bennett 980 Series Ventilator Recall Due to Manufacturing Defect
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing error where a capacitor was assembled incorrectly, which may cause the device 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 is classified as an FDA Class I recall. The FDA's rules establish that Class I recalls never score below 4, as they indicate potential for serious injury or death. Although no injuries or deaths have been reported, the risk that a ventilator may become inoperable during use poses a serious patient safety hazard.
Plain-English summary
The Puritan Bennett 980 Series Ventilator (model 980S3ENDICU) is being recalled by Covidien LLC due to a manufacturing assembly error involving a capacitor. The defect may cause the ventilator to become inoperable during use.
Approximately 278 units have been distributed worldwide, including throughout the United States. The affected units are identified by serial numbers 35B1700406, 35B1700449, 35B1700467, 35B1700469, 35B1700471, 35B1700474, 35B1700481, 35B1700526, and 35B1700558.
Healthcare facilities and individuals using affected ventilators should immediately contact Covidien for guidance on device replacement or repair. Patients dependent on this device should consult with their healthcare provider to ensure alternative respiratory support is available.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980S3ENDICU
- 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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