Recall Z-2433-2020— Codan US Corporation
Class II · Terminated
Class II FDA medical device recall by Codan US Corporation, initiated 2019-09-12, terminated 2021-04-28. It names one FDA 510(k) clearance: K033301. 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.. Reason: Individual packages of connectors may have incomplete or bad seals which would compromise sterility..
- Recalling firm
- Codan US Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-12
- Terminated
- 2021-04-28
- Firm location
- Santa Ana, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.