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U.S. Department of Health and Human Services

Enforcement Report - Week of September 26, 2012
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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter Lot numbers: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U Class II 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. 55,632 units Z-2418-2012
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter Lot numbers: 193S43, 193V47, 193W48, 1948E, 19494F, 194J4S, 194K4T, 294N4U, 296F6Q, 29767F, 297J7U, 297U87, 299199, 29929X, 29939Y, and 299X9H Class II 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. 152,016 units Z-2419-2012
Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter Lot numbers: 193J3R, 193M3T, and 294Q57 Class II 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. 30,408 units Z-2420-2012
Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter Lot numbers: 295W67, 295Y5K, 29656B, 296E6P, 296N72, and 296Y6J Class II 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. 80,208 units Z-2421-2012
Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter Lot number: 296S77 Class II 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. 1,536 units Z-2422-2012
Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter Lot number: 296T78 Class II 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. 24 units Z-2423-2012
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter Lot numbers: 193P3V and 295P62 Class II 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. 5184 units Z-2424-2012
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