Z-1844-2014 Class II Terminated
FDA device recall Z-1844-2014 was initiated by Nellcor Puritan Bennett Inc. (dba Covidien LP) on June 3, 2014 and is designated Class II. Reason for recall: 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 ve… The recall status is terminated (terminated August 22, 2016). Affected quantity: 104.
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2014
- Initiation Date
- June 3, 2014
- Termination Date
- August 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104
Product Description
Reason for Recall
Distribution Pattern
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