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Class 3 Device Recall HomeChoice PRO |
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Date Initiated by Firm |
December 23, 2002 |
Date Posted |
February 21, 2003 |
Recall Status1 |
Terminated 3 on December 11, 2007 |
Recall Number |
Z-0565-03 |
Recall Event ID |
25284 |
510(K)Number |
K012988
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Product Classification |
System, Peritoneal, Automatic Delivery - Product Code FKX
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Product |
HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R |
Code Information |
All HomeChoice PRO Systems with software versions 8.51 and 8.52. |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt 120 & Wilson Rd Round Lake IL 60073
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy
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FDA Determined Cause 2 |
Other |
Action |
Safety Alert letters dated 12/23/02 were mailed to the medical directos of facilities identified as having patients who use the low fill volume cassette with the HomeChoice machines. The letters informed them of the potential low ultrafiltrate volumes and requested that they review the patient list provided with the letter and verify that all of their patients who use the device in the low fill mode are included.
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Distribution |
Nationwide, Guatemala, Chile, Brazil, Turkey, Singapore, Taiwan, Canada, Belgium, Czech Republic, Israel, Italy, Jordan, Lebanon, Malta, Spain, Sweden, Turkey and the United Kingdom. |
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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