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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius FDS08 Dialysate Delivery Machine

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 Class 2 Recall
Fresenius FDS08 Dialysate Delivery Machine
see related information
Date Posted August 15, 2010
Recall Status1 Terminated on February 07, 2011
Recall Number Z-2226-2010
Recall Event ID 54546
Premarket Notification
510(K) Number
K911459 
Product Classification Dialysate Concentrate For Hemodialysis (Liquid Or Powder) - Product Code KPO
Product Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Code Information Catalog Numbers G047-80101 and RTLG047-80101
Recalling Firm/
Manufacturer
Fresenius Medical Care North America
920 Winter St
Waltham, Massachusetts 02451-1521
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 957
Distribution Product distributed to 5404 customers throughout the US and the world.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPO and Original Applicant = FRESENIUS USA, INC.
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