Puritan Bennett Ventilator Manual Labeling Correction for Oxygen Sensor Life
Nellcor Puritan Bennett is correcting operator and service manuals for PB700 and PB840 ventilators to clarify the operational life of the oxygen sensor.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding the operational life of a medical device component, which fits the criteria for moderate severity involving minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Nellcor Puritan Bennett Inc. (dba Covidien LP) is correcting labeling in the Puritan Bennett 700 Series (PB740 and PB760) and PB840 ventilator manuals. The correction clarifies the operational life of the oxygen sensors (PN 4-072214-00 and PN G-062010-00) used in these systems.
The recall addresses a discrepancy in the PB840 Operator's Manual, where an addendum incorrectly stated a nominal life of two years for the oxygen sensor, while the main manual stated one year. The affected documents are the PB700 Series Operator's Manual (PN 10066984 & PN G-061874-00) and the PB700 Series Service Manual (PN 10070389). The oxygen sensor is intended to provide the oxygen concentration of the delivered gas at the patient wye but does not control oxygen levels or gas flow.
The affected units were distributed worldwide, including the United States and numerous international locations. The total quantity of affected units is 7,959. Users should refer to the corrected labeling for accurate operational life information regarding the oxygen sensors.
The recalled product
- Product
- Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient…
- Manufacturer
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Category
- Medical Device — Ventilators
- Hazard
- Affected units
- 7,959
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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