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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter System 1000 Delivery System

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 Class 2 Device Recall Baxter System 1000 Delivery Systemsee related information
Date Initiated by FirmMarch 20, 2003
Date PostedMay 15, 2003
Recall Status1 Terminated 3 on January 23, 2004
Recall NumberZ-0833-03
Recall Event ID 25818
510(K)NumberK910215 
Product Classification System, Dialysate Delivery, Single Patient - Product Code FKP
ProductBaxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
Code Information Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 23764
FEI Number 1416980
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		The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
FDA Determined
Cause 2		Other
ActionBaxter sent recall letters dated 3/20/03 to the Medical Director and Hemodialysis Chief Technicians via first class mail on 3/20/03. The letters informed the accounts of the potential of running a treatment without bicarbonate due to an undetected bicarbonate pump stall following a sodium change, and provided instructions to change the B-A-alarm limits on the System 1000 Delivery Systems and confirm proper functionality after completing these changes. These changes will prevent undetected acid-only delivery in the event of a sodium level change
Quantity in Commerce25,014 units
DistributionThe devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Belgium, Bolivia, Brazil, Canada, Chile, China, Ecuador, Egypt, El Salvador, Guatemala, Honduras, Hong Kong, India, Mexico, Philippines, Singapore, South Korea, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.
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 = FKP
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