FDA Medical Device Recalls (openFDA)
Asahi Kasei Medical Co., Ltd., Okatomi Plant: Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
- Recall number
- Z-2422-2012
- Recalling firm
- Asahi Kasei Medical Co., Ltd., Okatomi Plant
- Product
- Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
- Status
- Terminated
- Initiated
- 2012-09-21
- Posted
- 2012-09-20
- Terminated
- 2013-02-05
- 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.
- 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
- 1,536 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
- Lot, serial or model codes
- Lot number: 296S77
- 510(k) numbers
- ["K082515"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3007340888
- Firm city
- Nobeoka-shi
- Firm state
- 5 Chome
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28