Puritan Bennett 840 Series Ventilator PB840 Operators Manual… — Class II medical device recall Z-0821-2014
Terminated recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), reported 2014-01-29, distributed nationwide. Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-
| Recall number | Z-0821-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder, CO, United States |
| Recall initiated | 2013-01-25 |
| Classified | 2014-01-23 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-11-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BH, BM, BO, BR, BZ, CA, CH, CL, CN, CO, CR, DE, EC, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, MA, MX, MY, NI, NL, OM, PA, PE, PH, PL, PY, QA, RO, RU, SA, SG, SI, SV, TH, TN, TR, TW, UY, VE, ZA |
| Quantity | 70,160 |
| Reason classes | labeling |
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 for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.