Recall Z-0822-2014— Nellcor Puritan Bennett Inc. (dba Covidien LP)

Name: FDA recall Z-0822-2014
Creator: U.S. Food and Drug Administration
Published: 2013-01-25

Class II · Terminated

Class II FDA medical device recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), initiated 2013-01-25, terminated 2014-11-24. It names 4 FDA 510(k) clearances: K990897, K984379, K970460 and 1 more. Product: 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.. Reason: 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..

Recalling firm: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Classification: Class II
Status: Terminated
Initiated: 2013-01-25
Terminated: 2014-11-24
Firm location: Boulder, CO, United States

510(k) clearances named in this recall

4 on FDA's record

K990897 — NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZERPuritan-Bennett Ireland, Ltd.·cleared 2000-03-15
K984379 — NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEMPuritan Bennett Corp.·cleared 1998-12-10
K970460 — NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)Puritan Bennett Corp.·cleared 1998-04-30
K964540 — NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEMPuritan Bennett Corp.·cleared 1997-11-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.