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Terminated

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.

FDA Recall Z-2433-2020 · Posted 2020-06-26

Recalling FirmCodan US Corporation
Recall StatusTerminated
Product CodeFPA
Date Initiated2019-09-12
Date Terminated2021-04-28
Product Quantity34,776 units

Reason for Recall

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

Firm 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.

Root Cause

Packaging process control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033301IV ADMINISTRATION AND CONNECT SETSCodan US Corp. · 2004-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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