Class 2 Device Recall CODAN SWANLOCK Swabable Needlefree Connector

• Date Initiated by Firm: September 12, 2019
• Date Posted: June 26, 2020
• Recall Status: Terminated 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/ Manufacturer: Codan US Corporation; 3511 W Sunflower Ave; Santa Ana CA 92704-6944
• For Additional Information Contact: Mr. Sam Y. Yu; 714-545-2111
• Manufacturer Reason for Recall: Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
• FDA Determined Cause: 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.