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Bayer Healthcare recalls PET Infusion Pump
Recalled November 23, 2016 · FDA recall Z-0400-2017 · 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. · FDA Class II
Units
165,127 (79,714 units in U.S.)
Sold at
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,
Description
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.
Product
PET Infusion Pump
Manufacturer(s)
Bayer Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →