• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Baxter

  • 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 1 Device Recall Baxter see related information
Date Initiated by Firm October 17, 2002
Date Posted February 06, 2003
Recall Status1 Terminated 3 on February 04, 2004
Recall Number Z-0506-03
Recall Event ID 25088
510(K)Number K811078  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter Y-Type Minivolume Extension Set; catalog 1C8499; Baxter Healthcare Corporation, Deerfield, IL 60015
Code Information All lots received prior to 10/23/2002
Recalling Firm/
Baxter Healthcare Corp.
Rt 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
Manufacturer Reason
for Recall
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
FDA Determined
Cause 2
Action Recalled by letter dated 10/17/02. Accounts were informed of the potential for the filters to be 1.2 micron filters instead of the 0.22. micron filters as labeled. The accounts were requested to examine their inventories for the affected catalog numbers and destroy the units found for credit.
Quantity in Commerce 13,104 units
Distribution Nationwide, Australia, Puerto Rico, Brazil, Canada, Sweden, New Zealand, Japan, Mexico, American Samoa, El Salvador, Turkey, Saudi Arabia, Austria, Cayman Islands, Macedonia, Honduras, Kuwait, Hong Kong and Nigeria.
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 = FPA and Original Applicant = TRAVENOL LABORATORIES, S.A.