Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2422-2012 — Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter

U.S. FDA — Device Enforcement · Japan · 2012-09-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2422-2012
Date of alert
2012-09-21
Country / jurisdiction
Japan
Risk level
Class II
Risk type
recall
Brand
Asahi Kasei Medical Co., Ltd., Okatomi Plant
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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