Puritan Bennett Ventilator Manual Addendum Corrected for Oxygen Sensor Life
Nellcor Puritan Bennett is correcting a labeling error in the PB840 Operator's Manual Addendum that incorrectly stated the oxygen sensor life as two years instead of one.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and labeling error (incorrect sensor life in the manual) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Nellcor Puritan Bennett Inc. (dba Covidien LP) is correcting labeling for the Puritan Bennett 840 Series Ventilator PB840 Operator's Manual Addendum (PN 066009A 09/02). The correction addresses the stated operational life of the oxygen sensor (O2 sensor) used in the ventilator systems.
The Operator's Manual for the PB840 correctly states a nominal life of one year for the oxygen sensor, but the Addendum incorrectly states a life of two years. This labeling discrepancy is being corrected to ensure accurate information regarding the sensor's operational life.
The affected units were distributed worldwide, including the United States and numerous international locations. The source text does not specify instructions for consumers or healthcare providers regarding immediate action, such as replacing the sensor or contacting the manufacturer, beyond the correction of the manual itself.
The recalled product
- Product
- Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 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 t
- Manufacturer
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Hazard
- Affected units
- 70,160
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- PB840 Operators Manual Addendum: PN 066009A 09/02
Distribution
Part of a larger recall action
This product is one of 2 recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) 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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