CLASS II Device recall · Reported 26 Sep 2012 · FDA Enforcement Report
Asahi Kasei, Rexeed(TM)- 18 LX, Hemodialyzer dialysis filter recalled
Asahi Kasei Medical Co., Ltd., Okatomi Plant is recalling Asahi Kasei, Rexeed(TM)- 18 LX, Hemodialyzer dialysis filter, distributed in Tennessee. The recall was initiated on 21 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2424-2012
- FDA event ID
- 63146
- Recalling firm
- Asahi Kasei Medical Co., Ltd., Okatomi Plant, Nobeoka-shi
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2012
- FDA classified
- 20 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 Sep 2012 | Classified by FDA | |
| 21 Sep 2012 | Recall initiated by company | +1 day |
| 26 Sep 2012 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Where it was distributed
REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
Questions about this recall
Is Asahi Kasei, Rexeed(TM)- 18 LX, Hemodialyzer dialysis filter recalled?
Yes. Asahi Kasei Medical Co., Ltd., Okatomi Plant recalled Asahi Kasei, Rexeed(TM)- 18 LX, Hemodialyzer dialysis filter on 21 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-2424-2012.
Why was it recalled?
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.
Which lots are affected?
Lot numbers: 193P3V and 295P62
Where was it sold?
REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Asahi Kasei Medical Co., Ltd., Okatomi Plant
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Asahi Kasei, Rexeed(TM)- 15 LX, Hemodialyzer dialysis filter recalled | Asahi Kasei Medical Co., Ltd., Okatomi Plant | Other | TN |
| Device | CLASS II | Asahi Kasei, Rexeed(TM)- 21 SX, Hemodialyzer dialysis filter recalled | Asahi Kasei Medical Co., Ltd., Okatomi Plant | Other | TN |
| Device | CLASS II | Asahi Kasei, Rexeed(TM)- 25 SX, Hemodialyzer dialysis filter recalled | Asahi Kasei Medical Co., Ltd., Okatomi Plant | Other | TN |
| Device | CLASS II | Asahi Kasei, Rexeed(TM)- 18 SX, Hemodialyzer dialysis filter recalled | Asahi Kasei Medical Co., Ltd., Okatomi Plant | Other | TN |
| Device | CLASS II | Asahi Kasei, Rexeed(TM)- 15 SX, Hemodialyzer dialysis filter recalled | Asahi Kasei Medical Co., Ltd., Okatomi Plant | Other | TN |
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