FDA-Device2020-07-08Class II

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.

Codan US Corporation
Hazard

Individual packages of connectors may have incomplete or bad seals which would compromise sterility.

Sold states
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.
Affected count
34,776 units
Manufactured in
3511 W Sunflower Ave, N/A, Santa Ana, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2433-2020

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