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Class 2 Device Recall Asahi KASEI, REXEED(TM) 15 SX, HEMODIALYZER |
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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
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Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
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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
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For Additional Information Contact |
Shinya Eguchi 901-362-6105
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = KDI and Original Applicant = ASAHI KASEI MEDICAL CO., LTD.
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