| ||Class 2 Recall|
SmartSite Needleless Connector
||February 03, 2014
|Recall Event ID
Set, Administration, Intravascular - Product Code FPA
||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.
10020 Pacific Mesa Blvd
San Diego, California 92121-4386
|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
|OTHER/UNDETERMINED: Under Investigation by the firm
||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, contact your distributor directly or call the CareFusion Support Center at numbers below.
For recall related questions, customers are instructed to contact CareFusion Support center at (888) 562-6018. For adverse event reports, customers are instructed to contact Customer advocacy at (888) 812-3266 or email firstname.lastname@example.org. For technical questions regarding the Alaris System, customers are instructed to contact technical support at (888) 812-3229.
|Quantity in Commerce
||3,500,000 units (2,136,200 units in US; 1,404,700 units foreign)
||Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = FPA and Original Applicant = Y