Home / Recalls / Asahi Kasei Medical Co., Ltd., Okatomi Plant / Z-2418-2012

Z-2418-2012 Class II Terminated

Recalled by Asahi Kasei Medical Co., Ltd., Okatomi Plant — Nobeoka-shi

Recall Details

Product Type
Devices
Report Date
September 26, 2012
Initiation Date
September 21, 2012
Termination Date
February 5, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
55,632 units

Product Description

Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter

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.

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

Code Information

Lot numbers: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U

Other recalls by Asahi Kasei Medical Co., Ltd., Okatomi Plant

  • Z-2420-2012 Class II — Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter (September 21, 2012)
  • Z-2424-2012 Class II — Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter (September 21, 2012)
  • Z-2423-2012 Class II — Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter (September 21, 2012)
  • Z-2422-2012 Class II — Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter (September 21, 2012)
  • Z-2419-2012 Class II — Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter (September 21, 2012)
  • Z-2421-2012 Class II — Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter (September 21, 2012)