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