Asahi Kasei Medical Co., Ltd., Okatomi Plant: Medical Device Recall in 2012 - (Recall #: Z-2418-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 21, 2012

Date Posted: September 26, 2012

Recall Number: Z-2418-2012

Event ID: 63146

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.

Status: Terminated

Product Quantity: 55,632 units

Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated