Reported May 21, 2014 · Terminated
Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number…
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nellcor Puritan Bennett Inc. (dba Covidien LP) · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214
Is this the product you have?
- Recalled product is a component of the Newport
- Medical Instruments e360 Ventilatorsingle board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency
- Lot codes and dates
- Part NumberSBC2105A
- Model Number(s)e360 Ventilator. Serial numbers N11360719000 through N14360426029
- Amount recalled
- 5,765
Where it was sold
Why it was recalled
Reports of the audible alarm not sounding when the ventilator is in an alarm state. The ventilator, as well as the visual and remote alarms, continue to operate normally.
This product could cause temporary or reversible health problems — stop using it.
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