FDA-Device2014-02-12Class II
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.
CareFusion 303, Inc.
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
Sold states
Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.
Affected count
3,500,000 units (2,136,200 units in US; 1,404,700 units foreign)
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0925-2014Don't want to check this manually?
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