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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Clearlink System Luer Activated Universal VIal Adapter

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  Class 2 Device Recall Baxter Clearlink System Luer Activated Universal VIal Adapter see related information
Date Initiated by Firm April 28, 2004
Date Posted November 16, 2004
Recall Status1 Terminated 3 on February 08, 2007
Recall Number Z-0194-05
Recall Event ID 29014
510(K)Number K003225  K006567  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter Clearlink System Luer Activated Universal VIal Adapter, product code 2N8395; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Code Information product code 2N8395, all lots
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
Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.
FDA Determined
Cause 2
Action An Urgent Device Correction letter and reply form dated 4/28/04 were sent to all U.S. Clearlink customers, informing them of the reports of increased infection rates abd describing the revision of the product labeling with additional statements that relate to product usage and reinforcement of standard clinical practices and proper aseptic technique. The revised labeling statements are as follows: * Ensure clamp is open. Swab Luer activated surface with preferred antiseptic prior to first use and before every subsequent connection. * Don not swab Luer activated surface when clamp is closed or valve is recessed. Ineffective swabbibg may result. Replace if valve remains recessed. * Flush Luer activated valve after blood infusion/sampling. If valve cannot be cleared of blood, replace immediately. * Luer lock vacutainer holders, syringes and accessories are recommended for blood sampling. If blood remains on valve surface after sampling, swab surface. * If intermittently disconnecting set from Luer activated valve, immediately cover male Luer with a sterile replacement protector.
Quantity in Commerce 67,098 units
Distribution Nationwide, and internationally through Baxter subsidiaries to Macedonia, Nigeria, Saudi Arabia, South Africa, Ireland, Italy, Denmark, Germany, the Netherlands, Hong Kong, Indonesia, Singapore, Spain, Belgium, Norway, United Kingdom, France and Luxembourg.
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.