Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN Recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) Due to Covidien is correcting labeling to clarify the operational...

Date: January 25, 2013
Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nellcor Puritan Bennett Inc. (dba Covidien LP) directly.

Affected Products

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.

Quantity: 70,160

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nellcor Puritan Bennett Inc. (dba Covidien LP)

Nellcor Puritan Bennett Inc. (dba Covidien LP) has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report