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U.S. Department of Health and Human Services

Class 3 Device Recall Asahi AMBIO D Series Hollow Fiber Dialyzers

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 Class 3 Device Recall Asahi AMBIO D Series Hollow Fiber Dialyzerssee related information
Date Initiated by FirmOctober 12, 2006
Date PostedNovember 14, 2006
Recall Status1 Terminated 3 on November 28, 2007
Recall NumberZ-0174-2007
Recall Event ID 36430
510(K)NumberK983720 
Product Classification Hollow Fiber Dialyzers - Product Code MSE
ProductAsahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-BIO-75D - 1.5 m2 surface area and Model AM-BIO-100D - 2.0 m2 surface area
Code Information Model AM-BIO-75D and Model AM-BIO-100D, all lots
FEI Number 1000599821
Recalling Firm/
Manufacturer		 Asahi Medical Co., Ltd
3100 Dundee Rd Ste 201/202
Northbrook IL 60062-2437
For Additional Information ContactMs. Karen Borling, R.N.
847-498-8500
Manufacturer Reason
for Recall		There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.
FDA Determined
Cause 2		Other
ActionAsahi sent Safety Alert letters on 10/12/06 to their re-use dialyzer customers advising them of the reports of difficulty separating the blood set from the dialyzer and not to use the Gambro Cartridge Blood Set with Asahi Reuse/Multiple Use Dialyzers in a reuse situation. Enclosed were copies of the temporary revision Instructions For Use with the following warning added at the top of the page: 'Additional Warning for Reuse/Multiple Use Dialyzers: Ashai Reuse/Multiple use dialyzers must not be used in connection with the Gambro cartridge Blood Set in a reuse environment.' Any questions were directed to Karen Borling, RN at 847-498-8500.
Quantity in Commerce100,000 for all models
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MSE
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