Recall Z-1053-2015— CareFusion 303, Inc.
Class II · Terminated
Class II FDA medical device recall by CareFusion 303, Inc., initiated 2015-01-13, terminated 2016-03-15. It names one FDA 510(k) clearance: K960280. 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.. Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-13
- Terminated
- 2016-03-15
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.