Reported Jan 29, 2014 · Terminated
Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual
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?
Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual
3 of 3 products
| Model / number | Product as published |
|---|---|
10066984 | & |
G-061874-00 | and PB700 Series Service Manual |
10070389 | The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients. |
- Lot codes and dates
- PB700 Series Operators
- ManualPN 10066984 & PN G-061874-00
- and PB700 Series Service ManualPN 10070389
- Amount recalled
- 7,959
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.
This product could cause temporary or reversible health problems — stop using it.
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