Recall Z-2423-2012— Asahi Kasei Medical Co., Ltd., Okatomi Plant
Class II · Terminated
Class II FDA medical device recall by Asahi Kasei Medical Co., Ltd., Okatomi Plant, initiated 2012-09-21, terminated 2013-02-05. It names one FDA 510(k) clearance: K082515. Product: Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter. 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..
- Recalling firm
- Asahi Kasei Medical Co., Ltd., Okatomi Plant
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-21
- Terminated
- 2013-02-05
- Firm location
- Nobeoka-shi, Japan
510(k) clearances named in this recall
1 on FDA's record- K082515 — ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.