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Class 2 Device Recall HomeChoice PRO & Yume Plus |
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Date Initiated by Firm |
November 01, 2004 |
Date Posted |
November 11, 2004 |
Recall Status1 |
Terminated 3 on December 11, 2007 |
Recall Number |
Z-0189-05 |
Recall Event ID |
30274 |
510(K)Number |
K012988
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Product Classification |
System, Peritoneal, Automatic Delivery - Product Code FKX
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Product |
HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, T5C8300, T5C8300R |
Code Information |
All units that do not bear the CE marking. |
Recalling Firm/ Manufacturer |
Baxter Healthcare Renal Div 1620 Waukegan Rd Bldg R Mc Gaw Park IL 60085-6730
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.
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FDA Determined Cause 2 |
Other |
Action |
Baxter sent Urgent Device Correction letters to the Peritoneal Dialysis Home Care Coordinators on 11/1/04 and to the Home Dialysis Patients on 11/2/04. The consignees were informed of the potential for a shock if the power switch loosens in the housing, and that the switch would be replaced with a grounded power switch on a next service call basis. If the patient experiences any difficulty turing the device on or off, or if they notice that the power switch is loose, they were instructed to immediately unplug the device and contact Baxter Global Technical Service (BGTS) at 1-800-553-6898, option 1, for immediate assistance. |
Quantity in Commerce |
10,800 units |
Distribution |
Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, Uruguay and Venezuela. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = FKX and Original Applicant = BAXTER HEALTHCARE CORP.
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