Reported Sep 26, 2012 · Terminated
Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Asahi Kasei Medical Co., Ltd., Okatomi Plant · 4960 5 Chome Nakagawara Cho · Nobeoka-shi · N/A
Is this the product you have?
- Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
- Lot codes and dates
- Lot numbers193P3V and 295P62
- Amount recalled
- 5184 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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