Z-2422-2012 Class II Terminated
FDA device recall Z-2422-2012 was initiated by Asahi Kasei Medical Co., Ltd., Okatomi Plant on September 21, 2012 and is designated Class II. 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 informati… The recall status is terminated (terminated February 5, 2013). Affected quantity: 1,536 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2012
- Initiation Date
- September 21, 2012
- Termination Date
- February 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,536 units
Product Description
Asahi KASEI, REXEED(TM)- 13 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.
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
Code Information
Lot number: 296S77