Home / Recalls / Nellcor Puritan Bennett Inc. (dba Covidien LP) / Z-0821-2014

Z-0821-2014 Class II Terminated

Recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP) — Boulder, CO

FDA device recall Z-0821-2014 was initiated by Nellcor Puritan Bennett Inc. (dba Covidien LP) on January 25, 2013 and is designated Class II. 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, an… The recall status is terminated (terminated November 24, 2014). Affected quantity: 70,160.

Recall Details

Product Type: Devices
Report Date: January 29, 2014
Initiation Date: January 25, 2013
Termination Date: November 24, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 70,160

Product Description

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.

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.

Code Information

PB840 Operators Manual Addendum: PN 066009A 09/02

Other recalls by Nellcor Puritan Bennett Inc. (dba Covidien LP)

Z-0112-2015 Class I — Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a h (October 1, 2014)
Z-0180-2015 Class I — Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC (October 1, 2014)
Z-2234-2014 Class II — Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electron (July 17, 2014)
Z-2235-2014 Class II — Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other ele (July 17, 2014)
Z-1809-2014 Class II — Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component (June 4, 2014)
Z-1844-2014 Class II — Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System (June 3, 2014)
Z-1577-2014 Class II — Recalled product is a component of the Newport Medical Instruments e360 Ventila (April 18, 2014)
Z-0822-2014 Class II — Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators (January 25, 2013)
Z-2301-2012 Class II — DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits ( (August 1, 2012)
Z-2174-2012 Class I — Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (W (July 18, 2012)