Recall Z-0821-2014 ยท CBK Ventilator, Continuous, Facility Use
Nellcor Puritan Bennett Inc. (dba Covidien LP)
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 continuo
| Date | Jan 24, 2014 (initiated Jan 25, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | The firm, Covidien, sent an "URGENT MEDICAL DEVICE VOLUNTARY FIELD CORRECTION" letter dated January 24, 2014 to its Consignees/customers via certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to read and understand the enclosed information; communicate this information to those who need to be aware of this labeling update; for the Puritan Bennett 840 ventilator only: If you have addendum P/N 066009A 09/02, remove and discard the addendum and replace it with the new information in Attachment I; for the Puritan Bennett 740 and 760 v |
| Quantity | 70,160 |
| Distribution | 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, Geo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964540 | NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM Puritan Bennett Corp., Nov 14, 1997 |
| K970460 | NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) Puritan Bennett Corp., Apr 30, 1998 |
| K984379 | NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM Puritan Bennett Corp., Dec 10, 1998 |
| K990897 | NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER Puritan-Bennett Ireland, Ltd., Mar 15, 2000 |