Z-2433-2020Class II

CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged...

Name: Z-2433-2020 CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged...
Creator: Codan US Corporation
Published: 2019-09-12
License: https://open.fda.gov/license/

Codan US Corp. / initiated 2019-09-12 / Terminated / root cause: packaging

FDA source

Codan US Corporation began a recall of 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... on 2019-09-12. FDA classified it as Class II and gives the reason as "Individual packages of connectors may have incomplete or bad seals which would compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2433-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-12
Posted: 2020-06-26
Terminated: 2021-04-28
Recalling firm: Codan US Corp.
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm issued recall letters dated 9/11/2019 via certified mail and email on 9/12/2019 requesting return or destruction of the affected product.
Quantity in commerce: 34,776 units
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.
Product codes and lots: Lot number 78503

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2433-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2433-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-26

Product code FPA

K033301Class IIIV Administration and Connect SetsCodan US Corp. / cleared 2004-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)