PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: February 11, 2015 Initiated: January 13, 2015 #Z-1053-2015

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.

Reason for Recall

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

Details

Recalling Firm
CareFusion 303, Inc.
Units Affected
7,440 units
Distribution
Nationwide Distribution
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by CareFusion 303, Inc.. Units affected: 7,440 units.
Why was this product recalled? ▼
CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2015. Severity: Moderate. Recall number: Z-1053-2015.

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