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U.S. Department of Health and Human Services

Class 2 Device Recall Phoenix Hemodialysis Delivery System

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  Class 2 Device Recall Phoenix Hemodialysis Delivery System see related information
Date Initiated by Firm September 10, 2007
Date Posted March 25, 2008
Recall Status1 Terminated 3 on January 03, 2012
Recall Number Z-1367-2008
Recall Event ID 45950
510(K)Number K001156  
Product Classification Dialysis system - Product Code KDI
Product Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401
Code Information All catalog numbers involving the Gambro Cartridge Blood Sets: 003409-400, 003409-410, 003410-500, 003410-510, 004310-710, 003411-500, 003412-500, 003414-500, 003414-510, 003415-510, 003422-500, 003422-515, 003422-520, 003429-500.
Recalling Firm/
Manufacturer		 Gambro Renal Products, Inc.
14143 Denver West Pkwy
Lakewood CO 80401-3116
For Additional Information Contact
303-231-4094
Manufacturer Reason
for Recall		 Kinked tubing on hemodialysis device may cause hemolysis.
FDA Determined
Cause 2		 Device Design
Action On September 10, 2007, the firm sent an Advisory Notice to all consignees alerting them that a kink in the tubing can result in physical hemolysis. The firm included with the Notice a Quick Reference Guide that provides drawing of the proper installation of the Phoenix and describes how to prevent bloodline kinking. A customer reply form was also included. The firm is in the process of making labeling changes that will be released with the updated software revisions.
Quantity in Commerce 41,000,000
Distribution Nationwide, including 17 VA facilities and 1 military facility. Foreign distribution to Canada, Korea, Mexico.
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 = GAMBRO RENAL PRODUCTS
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