Nellcor Puritan Bennett Inc. (dba Covidien LP): Medical Device Recall in 2014 - (Recall #: Z-0822-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 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.

Product Classification:

Class II

Date Initiated: January 25, 2013

Date Posted: January 29, 2014

Recall Number: Z-0822-2014

Event ID: 67163

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.

Status: Terminated

Product Quantity: 7,959

Code Information:

PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated