FDAFDA · Food and drugs·Recall number Z-0925-2014
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.
Published February 12, 2014 · Recall initiated: January 22, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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