FDA Device recall Z-2419-2012
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
- FDA Device
- Class II
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class II recall of Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter by Asahi Kasei Medical Okatomi Plant, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2419-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-21 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Asahi Kasei Medical Okatomi Plant |
| Distribution | TN |
Product
Asahi KASEI, REXEED(TM)- 18 SX, 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.
Identifiers
| code_info | Lot numbers: 193S43, 193V47, 193W48, 1948E, 19494F, 194J4S, 194K4T, 294N4U, 296F6Q, 29767F, 297J7U, 297U87, 299199, 29929X, 29939Y, and 299X9H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2419-2012%22
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