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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 FirmMay 28, 2003
Date PostedDecember 02, 2004
Recall Status1 Terminated 3 on February 26, 2008
Recall NumberZ-0395-05
Recall Event ID 30486
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 All System 1000 units with serial numbers prior to 22224.
FEI Number 3000210122
Recalling Firm/
Manufacturer		 Baxter Healthcare Renal Div
1620 Waukegan Rd Bldg R
Mc Gaw Park IL 60085-6730
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		The air detector may not detect air bubbles consistently at the selected limit.
FDA Determined
Cause 2		Other
ActionImportant Product Information letters were sent to customers on 5/28/03, informing them of the potential for the air detector not detecting air bubbles consistently. The letters instructed the accounts to measure the air detector sensor voltage output on each of their instruments, using the enclosed instructions, to determine whether the installation of an air detector attenuator connector is needed. The instructions also included directions for installation of the attenuator connector. Since the instrument requires re-qualification after the testing and installation, the accounts were given the choice to have the testing and installation done during the next service call or as part of the instrument''s next normally scheduled maintenance.
Quantity in Commerce28,482 units
DistributionThe devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, the Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Korea, Lebanon, Malaysia, Morocco, the Netherlands, Oman, Palestine, Panama, Peru, the Philippines, Poland, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, 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 = FKP
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