Recall Z-0925-2014— CareFusion 303, Inc.

Name: FDA recall Z-0925-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-22

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2014-01-22, terminated 2015-08-06. It names one FDA 510(k) clearance: K960280. Product: 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.. Reason: 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.

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-22
Terminated: 2015-08-06
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K960280 — IVAC NEEDLE FREE VALVE ADMINISTRATION SETSY·cleared 1996-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.