Device product
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.
Z-1053-2015
Product summary
- Event
- Event 70260
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,440 units
- Official record key
device-enforcement:Z-1053-2015
Official wording
Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
Code information: Lot No. 12056016, 12057027, and 12107105.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.