Recall Z-0925-2014 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
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.
| Date | Feb 3, 2014 (initiated Jan 22, 2014) |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated January 22, 2014 to customers. The letter described the product, problem and actions to be taken. Customers were instructed to discontinue use of the listed lot numbers, contact CareFusion for a replacement of the affected lots, and if you have inventory of the listed products immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card. All recalled product should be returned directly to the distributor from whom it was purchased. If you have any question |
| Quantity | 3,500,000 units (2,136,200 units in US; 1,404,700 units foreign) |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS Y, Apr 4, 1996 |