CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile.
FDA device recall Z-2433-2020 · posted 2020-06-26 · Terminated
Recall details
- Recalling firm
- Codan US Corporation
- Reason for recall
- Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 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.
- Date initiated
- 2019-09-12
- Date posted
- 2020-06-26
- Date terminated
- 2021-04-28
- Location
- Santa Ana, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IV ADMINISTRATION AND CONNECT SETS (K033301) | Codan US Corp. | 2004-03-04 |