Puritan Bennett 980 Series Ventilators Recalled for Incorrect Capacitor Assembly
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is classified as FDA Class I, which is a critical hazard designation. A ventilator that becomes inoperable during patient use presents an imminent danger to patient life.
Plain-English summary
Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators (model 980U3ESDIUU) that were distributed worldwide, including throughout the United States. These mechanical ventilators are used in healthcare settings to assist patients with breathing.
The recall is being issued due to a manufacturing defect in which capacitors within the ventilators were assembled incorrectly during production. This assembly error may cause affected ventilators to become inoperable during use.
Affected units can be identified using the following serial numbers: 35B1700548, 35B1700551, 35B1700560, 35B1700572, 35B1700577, 35B1700603, 35B1700606, and 35B1700615. Healthcare facilities and medical equipment users who possess these ventilators should contact Covidien immediately for instructions on replacement or repair.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Respiratory
- 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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