Recall Z-2433-2020 ยท FPA Set, Administration, Intravascular
Codan US Corporation
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.
| Date | Jun 26, 2020 (initiated Sep 12, 2019) |
| Status | Terminated |
| Reason | Individual packages of connectors may have incomplete or bad seals which would compromise sterility. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033301 | IV ADMINISTRATION AND CONNECT SETS Codan US Corp., Mar 4, 2004 |