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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 Device Recall Fresenius FDS08 Dialysate Delivery Machine 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-2227-2010
Recall Event ID 54546
510(K)Number K921456  
Product Classification System, Dialysate Delivery, Single Patient - Product Code FKP
Product Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
Code Information Catalog Numbers 190011 (60 Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC power cord assembly -hemodialysis machine) and 160089 (AC power cord assembly, Granuflo 1 mixers)
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 10267
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 = FKP and Original Applicant = FRESENIUS USA, INC.
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