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Asahi Kasei Medical Co., Ltd., Okatomi Plant recalls Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Recalled September 26, 2012 · FDA recall Z-2421-2012 · Asahi Kasei Medical Co., Ltd., Okatomi Plant
Hazard
Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products. · FDA Class II
Units
80,208 units
Sold at
REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
Description
Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.
Product
Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Manufacturer(s)
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →