Asahi KASEI recall
Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
Why was Asahi KASEI 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U
- Product
- Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
- Recalling firm
- Asahi Kasei Medical Co., Ltd., Okatomi Plant
- Quantity
- 55,632 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
- Recall date
- September 26, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)