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U.S. Department of Health and Human Services

Class 2 Device Recall CODAN SWANLOCK Swabable Needlefree Connector

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  Class 2 Device Recall CODAN SWANLOCK Swabable Needlefree Connector see related information
Date Initiated by Firm September 12, 2019
Date Posted June 26, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-2433-2020
Recall Event ID 85367
510(K)Number K033301  
Product Classification Set, administration, intravascular - Product Code FPA
Product CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA.
Code Information Lot number 78503
Recalling Firm/
Codan US Corporation
3511 W Sunflower Ave
Santa Ana CA 92704-6944
For Additional Information Contact Mr. Sam Y. Yu
Manufacturer Reason
for Recall
Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
FDA Determined
Cause 2
Packaging process control
Action The firm issued recall letters dated 9/11/2019 via certified mail and email on 9/12/2019 requesting return or destruction of the affected product.
Quantity in Commerce 34,776 units
Distribution Distribution was made to CA, MI, NY, PA, and VA. There was no military/government distribution. Foreign distribution was made to Canada, Australia, New Zealand, and Chile.
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 = CODAN US CORP.