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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter System 1000 Tina Hemodialysis Instrument

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 Class 2 Device Recall Baxter System 1000 Tina Hemodialysis Instrumentsee related information
Date Initiated by FirmSeptember 19, 2011
Date PostedNovember 07, 2011
Recall Status1 Terminated 3 on November 07, 2011
Recall NumberZ-0173-2012
Recall Event ID 60183
510(K)NumberK970446 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductBaxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis
Code Information product code S1000L3P, Serial Number 28130
Recalling Firm/
Manufacturer		 Baxter Healthcare Renal Div
1620 Waukegan Rd
Mc Gaw Park IL 60085-6730
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		The Tina System was released to the customer with OOS values for the Pressure Displays Accuracy and Leakage Rate Test.
FDA Determined
Cause 2		Employee error
ActionBaxter Healthcare Corporation sent a service technician to the lone customer site on September 19, 2011 to correct the affected product. The technician executed all tests as established in the Service Manual, with acceptable results.
Quantity in Commerce1 unit
DistributionDistributed in Puerto Rico only.
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 = KDI
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