FDA-Device2015-02-11Class II
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.
CareFusion 303, Inc.
Hazard
CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
Sold states
Nationwide Distribution
Affected count
7,440 units
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1053-2015Don't want to check this manually?
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