—#140871

Product

SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K960280
Affected lot / code info: Lot No. 15015769, 15035412, 15045950.

Why it was recalled

CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.

Root cause (FDA determination)

Process control

Action the firm took

An urgent medical device recall notification was sent to customers on 10/9/15 who purchased the SmartSite Extension Set. The letter informs the customers that CareFusion has identified potential risks with model code 20029E, lot numbers 1503541, 15015769 and 15045950 due to disconnection and leakage issues. The letter also provides the customers with the potential risk involved and the actions to be taken. Customers are instructed to complete and return to CareFusion the recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions regarding technical questions are instructed to contact Technical Support at (888) 812-3229.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: Distributed US (nationwide) and in Canada.

Timeline

Recall initiated: 2015-10-09
Posted by FDA: 2015-11-05
Terminated: 2017-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140871. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.