Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Baxter System 1000 Tina Hemodialysis Instrument

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Baxter System 1000 Tina Hemodialysis Instrument see related information
Date Initiated by Firm September 19, 2011
Date Posted November 07, 2011
Recall Status1 Terminated 3 on November 07, 2011
Recall Number Z-0173-2012
Recall Event ID 60183
510(K)Number K970446  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Baxter 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 Contact Center 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
Action Baxter 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 Commerce 1 unit
Distribution Distributed in Puerto Rico only.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KDI and Original Applicant = ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL
-
-