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U.S. Department of Health and Human Services

Class 2 Device Recall Asahi KASEI, REXEED(TM) 15 SX, HEMODIALYZER

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  Class 2 Device Recall Asahi KASEI, REXEED(TM) 15 SX, HEMODIALYZER see related information
Date Initiated by Firm September 21, 2012
Date Posted September 20, 2012
Recall Status1 Terminated 3 on February 05, 2013
Recall Number Z-2418-2012
Recall Event ID 63146
510(K)Number K082515  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER

dialysis filter
Code Information Lot numbers: 194349, 193T45, 193U46, 194H4R, 294S59, 295V68, 295Z5L, 29626X, and 296J6U
Recalling Firm/
Manufacturer		 Asahi Kasei Medical Co., Ltd., Okatomi Plant
4960 5 Chome Nakagawara Cho
Nobeoka-shi Japan
For Additional Information Contact Shinya Eguchi
901-362-6105
Manufacturer 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.
FDA Determined
Cause 2		 Process change control
Action AsahiKASEI Medical Co., LTD sent a Medical DeviceRecall letter on September 21, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm that they have no inventory and to forward the letter to all clinics who may have received the product requesting they check their stock and arrange for the return of any recalled product. Non-responding consignees will be contacted by telephone. For questions regarding this recall call Asaki Kasei Medical America, Inc. at 888-362-6105.
Quantity in Commerce 55,632 units
Distribution REXEED SX: Worldwide Distribution - USA including TN and the countries of Japan and Germany REXEED LX: Worldwide Distribution - USA including TN and Germany
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = ASAHI KASEI MEDICAL CO., LTD.
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