Asahi Kasei Medical Co., Ltd., Okatomi Plant: Medical Device Recall in 2012 - (Recall #: Z-2419-2012)

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)- 18 SX, HEMODIALYZER dialysis filter

Product Classification:

Class II

Date Initiated: September 21, 2012

Date Posted: September 26, 2012

Recall Number: Z-2419-2012

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: 152,016 units

Code Information:

Lot numbers: 193S43, 193V47, 193W48, 1948E, 19494F, 194J4S, 194K4T, 294N4U, 296F6Q, 29767F, 297J7U, 297U87, 299199, 29929X, 29939Y, and 299X9H

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