Home / Recalls / Asahi Kasei Medical Co., Ltd., Okatomi Plant / Z-2419-2012

Z-2419-2012 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
152,016 units

Product Description

Asahi KASEI, REXEED(TM)- 18 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: 193S43, 193V47, 193W48, 1948E, 19494F, 194J4S, 194K4T, 294N4U, 296F6Q, 29767F, 297J7U, 297U87, 299199, 29929X, 29939Y, and 299X9H

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-2418-2012 Class II — Asahi KASEI, REXEED(TM)- 15 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-2421-2012 Class II — Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter (September 21, 2012)