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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012

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Product Detail

Product Description Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Recall Number Z-2418-2012
Classification Class II
Code Info Lot numbers: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U
Product Distributed Qty 55,632 units
Reason For Recall 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.

Event Detail

Event Id 63146
Product Type Devices
Status Ongoing
Recalling Firm Asahi Kasei Medical Co., Ltd., Okatomi Plant
City Nobeoka-shi
State
Country JP
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
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