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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Interlink System NonDEHP YType Catheter Extension Set

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  Class 2 Device Recall Baxter Interlink System NonDEHP YType Catheter Extension Set see related information
Date Initiated by Firm December 15, 2005
Date Posted March 24, 2006
Recall Status1 Terminated 3 on August 18, 2008
Recall Number Z-0625-06
Recall Event ID 34290
510(K)Number K003225  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N8371; An Rx sterile, nonpyrogenic fluid pathway, 6.0'', 1.0 mL Vol., with 2 Luer Activated Valves and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Code Information product code 2N8371, lots UR254482, UR254763, UR255752
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 extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
FDA Determined
Cause 2
Other
Action Baxter sent Urgent Product Recall letters dated 8/3/05 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 microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. 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. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
Quantity in Commerce 29,200 sets
Distribution Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Australia, Japan, South Korea, Saudi Arabia, India, Mexico, Venezuela, Malaysia, East Timor and New Zealand.
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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