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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85367

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 12, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Codan US Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-2433-2020
Initiated
September 12, 2019
Classification
Class II
Status
Terminated
Recalling firm
Codan US Corporation
Quantity
34,776 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packages of connectors may have incomplete or bad seals which would compromise sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.