CareFusion 303, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1053-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: January 13, 2015

Date Posted: February 11, 2015

Recall Number: Z-1053-2015

Event ID: 70260

Reason for Recall:

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

Status: Terminated

Product Quantity: 7,440 units

Code Information:

Lot No. 12056016, 12057027, and 12107105.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated