Skip to content
Recall Observatory FDA recall evidence

Device product

Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter

Z-2424-2012

September 21, 2012

Class II

Product summary

Firm
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Event
Event 63146
Status
Terminated
Classification
Class II
Quantity
5184 units
Official record key
device-enforcement:Z-2424-2012

Official wording

Reason: 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.

Code information: Lot numbers: 193P3V and 295P62

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.