| Class 2 Device Recall CODAN SWANLOCK Swabable Needlefree Connector | |
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/ 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 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
|
|
|
|