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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Interlink System YType Minivolume Extension Set

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  Class 2 Device Recall Baxter Interlink System YType Minivolume Extension Set see related information
Date Initiated by Firm July 06, 2005
Date Posted August 06, 2005
Recall Status1 Terminated 3 on January 31, 2007
Recall Number Z-1102-05
Recall Event ID 32588
510(K)Number K925126  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Code Information product code 1C8645, lots GR222042, GR224667, GR227173, GR228114; 
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
Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
FDA Determined
Cause 2
Other
Action Baxter sent Urgent Product Recall letters dated 7/6/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the complaints of leaks and disconnection between the bifurcated Y-site and the set tubing, resulting in the possible under delivery of medication, blood loss and a breach of the sterile fluid pathway. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
Quantity in Commerce 8,256 sets
Distribution Arizona, Georgia, Illinois, Michigan, Ohio, Pennsylvania, South Carolina and Texas.
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.
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