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The U.S. Food and Drug Administration has issued a Class II recall of some lots of the Asahi Kasei Rexeed 15SX hemodialyzer dialysis filters. Asahi said they became aware of adverse events that may be associated with a manufacturing change to certain lot numbers of the products, but they said there is no sufficient information to date to conclusively link these adverse events to the products.
The following lot numbers are affected: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U