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U.S. Department of Health and Human Services

Class 2 Device Recall Phoenix Hemodialysis machine.

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  Class 2 Device Recall Phoenix Hemodialysis machine. see related information
Date Initiated by Firm May 12, 2006
Date Posted November 21, 2006
Recall Status1 Terminated 3 on January 03, 2012
Recall Number Z-0200-2007
Recall Event ID 36233
510(K)Number K001156  
Product Classification Hemodialysis - Product Code KDI
Product Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
Code Information Serial numbers: 11637 thru 12321.
Recalling Firm/
Manufacturer		 Gambro Renal Products, Inc.
10810 W Collins Ave
Lakewood CO 80215-4439
For Additional Information Contact Tom Dowell
303-231-4094
Manufacturer Reason
for Recall		 Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified by fax on 05/12/2006 and by letter on 05/16/2006. Until it was determined that their Phoenix system did not have an affected heat exchanger, users were instructed to disinfect the hydraulics flow path after each patient treatment. Gambro personnel will inspect each system and replace any affected heat exchangers.
Quantity in Commerce 613 machines (US), 170 machines (foreign)
Distribution Worldwide Distribution, USA, including VA facilities in GA and NC. Foreign distribution to Canada, Korea and 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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