Puritan Bennett 840 Ventilator recall
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and…
Why was Puritan Bennett 840 Ventilator recalled?
Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
serial number 3510100714 to 3512101160 and any units in which a replacement PSU was installed between March 2010 and September of 2010.
- Product
- Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and…
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Quantity
- 104
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, Germany, Guatemala, Israel, Japan, Kazakhstan, Kenya, Lebanon, Libya, Macedonia, Mexico, Montenegro, Morocco, Panama, Peru, Russia, Saudi Arabia, Singapore, Switzerland, Taiwan, Tunisia, Turkey, Yugoslavia (Serbia & Montenegro) Including GOVT/VA/Military
- Recall date
- July 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)