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U.S. Department of Health and Human Services

Class 2 Device Recall ContinuFlo Solution Set with Large Bore 4Way Stopcock Extension Set

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  Class 2 Device Recall ContinuFlo Solution Set with Large Bore 4Way Stopcock Extension Set see related information
Date Initiated by Firm April 21, 2005
Date Posted June 30, 2005
Recall Status1 Terminated 3 on July 19, 2006
Recall Number Z-0943-05
Recall Event ID 31800
510(K)Number K022895  
Product Classification Stopcock, I.V. Set - Product Code FMG
Product Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids; Manufactured by an affiliate of Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in Costa Rica
Code Information product code 3C0062s, lot numbers R04D28173, R04D28181, R04D28199, R04F22288, R04F23237, R04F25273, R04G24100, R04G26071, R04H12020, R04H13085, R04H13242, R04H30303, R04I21151, R04J06227, R04J07076, R04J07092, R04J28122, R04K08064, R04K08221, R04K26090, R04K29086, R04L09110, R04L17055, R04L17188, R04L18137, R05A20092, R05A20217, R05B03187, R05B04060, R05B28192
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
There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.
FDA Determined
Cause 2
Action Recall letters dated 4/21/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Materials Management. The accounts were informed of the reports of an unsecure connection between the male luer and the stopcock due to silicone on the male luer tip, and were requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit.
Quantity in Commerce 107,832 sets
Distribution Nationwide and internationally to American Samoa and Venezuela.
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 = FMG and Original Applicant = MEDICAL DEVICE CONSULTANTS, INC.