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Recall Observatory FDA recall evidence

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

January 13, 2015

Class II

Product summary

Firm
CareFusion 303, Inc.
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

    reason.no_named_rule · v1.0.0

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