CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report

Puritan Bennett 840 Series Ventilator PB840 Operators recalled

Nellcor Puritan Bennett Inc. ( is recalling Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02, distributed nationwide in the US. The recall was initiated on 25 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPB840 Operators Manual Addendum: PN 066009A 09/02

Quantity recalled70,160

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0821-2014
FDA event ID: 67163
Recalling firm: Nellcor Puritan Bennett Inc. (, Boulder, CO
Classification: Class II
Status: Terminated
Recall initiated: 25 Jan 2013
FDA classified: 23 Jan 2014
Reported: 29 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: CPAP & Ventilators

Timeline

25 Jan 2013	Recall initiated by company
23 Jan 2014	Classified by FDA	+363 days
29 Jan 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution: US (nationwide) and Internationally to: Albania, Argentina, Australia, Bahrain, Belgium, Belize, Bermuda Bolivia, Bosnia and Herzegovina, Brazil, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, The former Yugoslav, Malaysia, Mexico, Moldova, Republic of, Montenegro, Morocco, Netherlands, Nicaragua, Northern Mariana Islands, Oman, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukrainian SSR, United Arab Emirates (UAE) United Kingdom, Uruguay, Venezuela and Yugoslavia.

Nationwide Georgia Puerto Rico

Questions about this recall

Is Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 recalled?

Yes. Nellcor Puritan Bennett Inc. ( recalled Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 on 25 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-0821-2014.

Why was it recalled?

Which lots are affected?

PB840 Operators Manual Addendum: PN 066009A 09/02

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Nellcor Puritan Bennett Inc. (

All 11

Reported	Class	Recall	Company	Reason	Where
17 Dec 2014Device	CLASS I	Covidien Puritan Bennett 980 Ventilator recalled	Nellcor Puritan Bennett Inc. (	Other	Nationwide
5 Nov 2014Device	CLASS I	Covidien Puritan Bennett 980 Ventilator recalled	Nellcor Puritan Bennett Inc. (	Lead & Heavy Metals	17 states
20 Aug 2014Device	CLASS II	Vital Sync RMS 0 when loaded with v2.4 recalled	Nellcor Puritan Bennett Inc. (	Packaging Defects	8 states
20 Aug 2014Device	CLASS II	Vital Sync" VPMP & IM recalled by Nellcor Puritan Bennett Inc. (	Nellcor Puritan Bennett Inc. (	Packaging Defects	8 states
2 Jul 2014Device	CLASS II	Puritan Bennett 840 Ventilator recalled	Nellcor Puritan Bennett Inc. (	Device Malfunction	Nationwide

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