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U.S. Department of Health and Human Services

Class 2 Device Recall Toray Toraysulfone Hollow Fiber Dialyzer

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  Class 2 Device Recall Toray Toraysulfone Hollow Fiber Dialyzer see related information
Date Initiated by Firm December 30, 2003
Date Posted January 14, 2004
Recall Status1 Terminated 3 on February 03, 2004
Recall Number Z-0352-04
Recall Event ID 28027
510(K)Number K002512  
Product Classification Dialyzer, Capillary, Hollow Fiber - Product Code FJI
Product Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8
Code Information Lot numbers: 20310140, 20910540, and 20910541. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual unit or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.)
Recalling Firm/
Manufacturer		 Toray Marketing & Sales (America), Inc
140 Cypress Station Dr Ste 210
Houston TX 77090-1627
Manufacturer Reason
for Recall		 Potential loose header (end cap) on hollow fiber dialyzers.
FDA Determined
Cause 2		 Other
Action Firm notified all consignees by phone call on 1/2/2004 and 1/5/2004. Firm is also notifying all consignees by letter with a response form, sent by certified mail.
Quantity in Commerce 384 units
Distribution California, New Jersey, Florida, Texas, Ohio, Wisconsin, New York, and Washington.
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 and Original Applicant = TORAY INDUSTRIES (AMERICA), INC.
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