Z-2421-2012Class II

Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter

Name: Z-2421-2012 Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Creator: Asahi Kasei Medical Co., Ltd., Okatomi Plant
Published: 2012-09-21
License: https://open.fda.gov/license/

Asahi Kasei Medical Co., Ltd., Okatomi Plant / initiated 2012-09-21 / Terminated / root cause: manufacturing process

FDA source

Asahi Kasei Medical Co., Ltd., Okatomi Plant began a recall of Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter on 2012-09-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2421-2012
Classification: Class II
Status: Terminated
Initiated: 2012-09-21
Posted: 2012-09-20
Terminated: 2013-02-05
Recalling firm: Asahi Kasei Medical Co., Ltd., Okatomi Plant
Product: Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: AsahiKASEI Medical Co., LTD sent a Medical DeviceRecall letter on September 21, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm that they have no inventory and to forward the letter to all clinics who may have received the product requesting they check their stock and arrange for the return of any recalled product. Non-responding consignees will be contacted by telephone. For questions regarding this recall call Asaki Kasei Medical America, Inc. at 888-362-6105.
Quantity in commerce: 80,208 units
Distribution: REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
Product codes and lots: Lot numbers: 295W67, 295Y5K, 29656B, 296E6P, 296N72, and 296Y6J

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2421-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2418-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2419-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2420-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2421-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2422-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2423-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20
Z-2424-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-20

Product code KDI

K082515Class IIAsahi Rexeed-Sx/lx Dialyzers, Models: 13Sx, 15Sx, 18Sx, 21Sx, 25Sx, 13Lx, 15Lx, 18Lx, 21LxAsahi Kasei Medical Co., Ltd. / cleared 2008-10-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)