FDA recall Z-2433-2020

Codan US Corporation · Class II · device

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 for recall

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

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.

Key facts

Status
Terminated
Initiation date
2019-09-12
Report date
2020-07-08
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Ana, CA, United States

Primary source

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