Enforcement Report - Week of September 26, 2012
-
Back to Previous Page
Product Detail
| Product Description | Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter |
|---|---|
| Recall Number | Z-2421-2012 |
| Classification | Class II |
| Code Info | Lot numbers: 295W67, 295Y5K, 29656B, 296E6P, 296N72, and 296Y6J |
| Product Distributed Qty | 80,208 units |
| 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. |
Event Detail
| Event Id | 63146 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Asahi Kasei Medical Co., Ltd., Okatomi Plant |
| City | Nobeoka-shi |
| State | Country | JP |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany |
-
