The ban applies to Gambro’s Prisma, Prismaflext and Phoenix monitors for kidney dialysis. The FDA stopped imports and sent a warning letter to the company after an inspection of Gambro’s monitor factory in Medolla, Italy. The agency criticised the instructions for using the machines, among other things.
Gambro has headquarters in Stockholm and employs 900 people in Lund.
Spokeswoman Paula Treutiger said that there “are no faults whatsoever with the machines.”
“The FDA has concerns about the security of the system, and we are now making sure that it is used correctly,” she said.
Imports to America will in the first instance be banned for fifteen days, during which time the company will put together a response to the FDA’s concerns.
Gambro’s share price fell on the Stockholm stock exchange after the news of the ban became public.