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.

Recall

• Recall Number: Z-0221-2016
• Event Number: 72384
• Firm: CareFusion 303, Inc.
• FEI Number: 2016493
• Product Code: FPA
• Status: Terminated
• Root Cause: Process control
• Initiated: October 9, 2015
• Posted: November 5, 2015
• Terminated: March 2, 2017
• Address: 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

Description

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.

Reason

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

Action

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 [phone]. Customers with adverse event reports are instructed to contact Customer Advocacy at [phone] or email [email protected]. Customers with technical questions regarding technical questions are instructed to contact Technical Support at [phone].

Distribution

Distributed US (nationwide) and in Canada.

Quantity

21,000 units

Device

• Product Code: FPA
• Device: Set, Administration, Intravascular
• Class: Class 2
• Specialty: General Hospital