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U.S. Department of Health and Human Services

Class 1 Device Recall Baxter

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  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-0519-03
Recall Event ID 25088
510(K)Number K915390  K791496  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter Microbore 3-Lead Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3342; Baxter Healthcare Corporation, Deerfield, IL 60015; 50 units per case
Code Information All lots received prior to 10/23/2002
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
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		 Other
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 130,040 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 = BAXTER HEALTHCARE CORP.
510(K)s with Product Code = FPA and Original Applicant = TRAVENOL LABORATORIES, S.A.
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