FDAFDA · Food and drugs·Recall number Z-0822-2014
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.
Published January 29, 2014 · Recall initiated: January 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Distributor
- 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.
- Lot
- PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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