FDA Medical Device Recalls (openFDA)
Codan US Corporation: 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.
- Recall number
- Z-2433-2020
- Recalling firm
- Codan US Corporation
- 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.
- Status
- Terminated
- Initiated
- 2019-09-12
- Posted
- 2020-06-26
- Terminated
- 2021-04-28
- Reason
- Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
- 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
- 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.
- Lot, serial or model codes
- Lot number 78503
- 510(k) numbers
- ["K033301"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2016945
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28