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U.S. Department of Health and Human Services

Class 3 Device Recall Spanish Patient AtHome Guide for the HomeChoice/HomeChoice Pro

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  Class 3 Device Recall Spanish Patient AtHome Guide for the HomeChoice/HomeChoice Pro see related information
Date Initiated by Firm September 12, 2005
Date Posted November 16, 2005
Recall Status1 Terminated 3 on July 19, 2006
Recall Number Z-0139-06
Recall Event ID 32323
510(K)Number K012988  
Product Classification System, Peritoneal, Automatic Delivery - Product Code FKX
Product Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.
Code Information All Spanish language Patient At-Home Guides, with item numbers other than item #157-1260-806ES Rev. A 7/04 printed on teh back cover of the manual
Recalling Firm/
Manufacturer		 Baxter Healthcare Renal Div
1620 Waukegan Rd Bldg R
Mc Gaw Park IL 60085-6730
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 The Spanish language patient operating manual called the Patient At-Home Guide, was not updated when several warnings were added to the English version that may assist the operator in the safe and effective operation of the home dialysis machine.
FDA Determined
Cause 2		 Other
Action An Urgent Device Correction letter was sent in Spanish and English, along with the new Spanish Patient At-Home Guide, item 157-1260-806ES, to Spanish-only speaking customers and their affiliated facilities on 9/12/05. The letters highlighted the additions to the Patient At-Home Guide and asked the customers to review them carefully and to use the new guide from this point forward to assist them in the safe and effective operation of their HomeChoice/HomeChoice PRO machine. They were instructed to discard any previous versions of the guide. Any questions were directed to Baxter DIalysis Patient Services at 1-800-2824-4060.
Quantity in Commerce 524 manuals
Distribution Nationwide
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 = FKX and Original Applicant = BAXTER HEALTHCARE CORP.
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