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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67346

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

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Event summary

Timeline bucket
January 22, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CareFusion 303, Inc.

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

SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.

Z-0925-2014
Recall number
Z-0925-2014
Initiated
January 22, 2014
Classification
Class II
Status
Terminated
Recalling firm
CareFusion 303, Inc.
Quantity
3,500,000 units (2,136,200 units in US; 1,404,700 units foreign)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in

Code information

Lot Numbers: 13045933 13046117 13086415 13086446 13095237 13095302 13095324 13095579 13095674 13095675 13095777 13095778 13095808 13095944 13096011 13096012 13096013 13096158 13096723 13096770 13105584 13106017 13106018 13106096 13106260 13106355 13106451 13106497 13106498 13106753 13106754 13106847 13106848 13106849 13115209 13115210 13115317 13115733 13115734 13115871 13115872 13125361 13125362

Distribution pattern

Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.