FDA Device recall Z-0821-2014
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide…
- FDA Device
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide… by Nellcor Puritan Bennett Dba Covidien, citing 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 Pur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0821-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-25 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nellcor Puritan Bennett Dba Covidien |
| Distribution | US |
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 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.
Reason
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.
Identifiers
| code_info | PB840 Operators Manual Addendum: PN 066009A 09/02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0821-2014%22
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