Skip to content
Recall Observatory FDA recall evidence

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.

Z-2433-2020

September 12, 2019

Class II

Product summary

Firm
Codan US Corporation
Event
Event 85367
Status
Terminated
Classification
Class II
Quantity
34,776 units
Official record key
device-enforcement:Z-2433-2020

Official wording

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

Code information: Lot number 78503

Distribution pattern: 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.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

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