Class 3 Device Recall Asahi AMR Series Hollow Fiber Dialyzers

• Date Initiated by Firm: October 12, 2006
• Date Posted: November 14, 2006
• Recall Status: Terminated on November 28, 2007
• Recall Number: Z-0175-2007
• Recall Event ID: 36430
• 510(K)Number: K991512
• Product Classification: Hollow Fiber Dialyzers - Product Code FJI
• Product: Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon 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-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area
• Code Information: Model AM-NR-65U, Model AM-NR-75U and Model AM-NR-100U, 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 Contact: Ms. 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: Other
• Action: Asahi 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 Commerce: 100,000 for all models
• Distribution: Nationwide
• 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 = FJI