Recalls / —
—#132712
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.
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K960280
- Affected lot / code info
- Lot No. 12056016, 12057027, and 12107105.
Why it was recalled
CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
CareFusion sent an Urgent Medical Device Recall Notification letter dated January 13, 2015, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return to CareFusion the recall response card. Customers with questions were instructed to CareFusion: Recall related questions, (888) 562-6018; Adverse Event Reports, (888) 812-3266; Technical Questions regarding the Alaris System, (888) 812-3229.
Recalling firm
- Firm
- CareFusion 303, Inc.
- Address
- 10020 Pacific Mesa Blvd, San Diego, California 92121-4386
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2015-01-13
- Posted by FDA
- 2015-02-04
- Terminated
- 2016-03-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #132712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.