Z-1053-2015Class II

SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer...

Name: Z-1053-2015 SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer...
Creator: CareFusion 303, Inc.
Published: 2015-01-13
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2015-01-13 / Terminated

FDA source

CareFusion 303, Inc. began a recall of SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter... on 2015-01-13. FDA classified it as Class II and gives the reason as "CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1053-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-13
Posted: 2015-02-04
Terminated: 2016-03-15
Recalling firm: CareFusion 303, Inc
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 7,440 units
Distribution: Nationwide Distribution
Product codes and lots: Lot No. 12056016, 12057027, and 12107105.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1053-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1053-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-04

Product code FPA

K960280Class IIIvac Needle Free Valve Administration SetsY / cleared 1996-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)