FDA-Device2016-11-23Class II
PET Infusion Pump
Bayer Healthcare
Hazard
The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.
Sold states
Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Netherlands, Mexico, Malta, Morraco, Libyan, Lithuania, Lebanon, Kuwait, Italy, Israel, Hungray, United Kingdom, France, Finland, Spain, Denmark, Germany, Czech Republic, Chile, Switzerland, Belguim, Bosnia, Austria, Australia,
Affected count
165,127 (79,714 units in U.S.)
Manufactured in
1 Bayer Dr, N/A, Indianola, PA, United States
Products
PET Infusion Pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0400-2017Don't want to check this manually?
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