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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius 2008K, 2008K2 and 2008K2home Hemodialysis Machines

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  Class 2 Device Recall Fresenius 2008K, 2008K2 and 2008K2home Hemodialysis Machines see related information
Date Initiated by Firm November 20, 2009
Date Posted August 15, 2010
Recall Status1 Terminated 3 on February 07, 2011
Recall Number Z-2225-2010
Recall Event ID 54546
510(K)Number K994267  
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Product Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Code Information Catalog numbers: 2008K: 190300, 190303, 190305, 190336, 190371, 190372, 190373, 190517, R190305 (Refurbished), R190371 (Refurbished), RTL190371, RTL190373, RTLR190305 (Refurbished), RTLR190371 (Refurbished), RTLR190373 (Refurbished)
Recalling Firm/
Manufacturer		 Fresenius Medical Care North America
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall		 Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
FDA Determined
Cause 2		 Component design/selection
Action An urgent device recall notification was sent to all consignees. Customers are asked to inspect cords for defects, and are refered to preventive maintenance requirements in the manual. Customers who identify the defective cords will be instructed to discontinue use as soon as possible without jeopardizing patient care. Customers are instructed to monitor cords regularly, and pay attention to machines that are frequently plugged or unplugged. Personnel are instructed to not use the cord to unplug the device from the wall (yanking the plug from the wall) and to refrain from rolling over the cord or plug.
Quantity in Commerce 60885
Distribution Product distributed to 5404 customers throughout the US and the world.
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 = FRESENIUS MEDICAL CARE
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