FDAFDA · Food and drugs·Recall number Z-2419-2012
Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
Published September 26, 2012 · Recall initiated: September 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Asahi Kasei Medical Co., Ltd., Okatomi Plant
- Distributor
- REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
- Lot
- Lot numbers: 193S43, 193V47, 193W48, 1948E, 19494F, 194J4S, 194K4T, 294N4U, 296F6Q, 29767F, 297J7U, 297U87, 299199, 29929X, 29939Y, and 299X9H
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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