FDA-Device2012-09-26Class II
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
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.
Sold states
REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
Affected count
5184 units
Manufactured in
4960 5 Chome Nakagawara Cho, Nobeoka-shi, Japan
Products
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2424-2012Don't want to check this manually?
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