Puritan Bennett 560 Ventilator Recalled for Loss of Gas Supply
Covidien is recalling the Puritan Bennett 560 Ventilator due to a manufacturing error in turbine components that causes loss of gas supply and device inoperability. Six incidents have been confirmed from customers outside the United States.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a life-support respiratory device with a confirmed manufacturing defect causing inoperability. While six reports of the defect have been confirmed in the field, no illnesses or injuries have been reported, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Puritan Bennett 560 Ventilator (Model PB560, CFN 4096600) manufactured by Covidien is being recalled due to a manufacturing error in specific turbine components. This defect can cause loss of gas supply to the ventilator, rendering it inoperable.
Six reports have been confirmed from customers outside the United States documenting instances where the ventilator became inoperable due to loss of gas supply. In the US, the affected devices were distributed to one customer in Washington, D.C., while international distribution occurred worldwide.
Affected units include five devices in the US with serial numbers 40966N7229, 40966N7231, 40966N7334, 40966N7335, and 40966N7340 (UDI-DI: 10884521196377). Users should verify their device serial numbers and contact Covidien immediately if they possess an affected unit to arrange for replacement or repair.
The recalled product
- Product
- Puritan Bennett 560 Ventilator, PB560, CFN 4096600
- Manufacturer
- Covidien Llc
- Affected units
- 5
Distribution
Distributed in 1 state:
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