SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

Recall

• Recall Number: Z-1053-2015
• Event Number: 70260
• Firm: CareFusion 303, Inc.
• FEI Number: 2016493
• Product Code: FPA
• Status: Terminated
• Root Cause: Under Investigation by firm
• Initiated: January 13, 2015
• Posted: February 4, 2015
• Terminated: March 15, 2016
• Address: 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

Description

SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

Reason

CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

Action

CareFusion sent an Urgent Medical Device Recall Notification letter dated January 13, 2015, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return to CareFusion the recall response card. Customers with questions were instructed to CareFusion: Recall related questions, [phone]; Adverse Event Reports, [phone]; Technical Questions regarding the Alaris System, [phone].

Distribution

Nationwide Distribution

Quantity

7,440 units

Device

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