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U.S. Department of Health and Human Services

Class 3 Device Recall HomeChoice PRO

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 Class 3 Device Recall HomeChoice PROsee related information
Date Initiated by FirmDecember 23, 2002
Date PostedFebruary 21, 2003
Recall Status1 Terminated 3 on December 11, 2007
Recall NumberZ-0565-03
Recall Event ID 25284
510(K)NumberK012988 
Product Classification System, Peritoneal, Automatic Delivery - Product Code FKX
ProductHomeChoice 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
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy
FDA Determined
Cause 2		Other
ActionSafety 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.
DistributionNationwide, 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 CycleTPLC 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) Database510(K)s with Product Code = FKX
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