Z-2279-2013Class II

SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to...

Name: Z-2279-2013 SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to...
Creator: CareFusion 303, Inc.
Published: 2013-08-30
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2013-08-30 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or... on 2013-08-30. FDA classified it as Class II and gives the reason as "CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2279-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Posted: 2013-09-26
Terminated: 2013-10-28
Recalling firm: CareFusion 303, Inc
Product: SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: CareFusion sent an Urgent Medical Device Recall Notification dated August 30, 2013, to all affected customers. The letter informed the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers were instructed to immediately check their inventory for the affected product, if any affected product is encountered, customers were instructed not to use. Customers were instructed to complete the customer response form and return the form to CareFusion with the affected product for replacement.. A distributor letter was also sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors were instructed to contact the Customer Support Team, return customer response form, and if they have questions then they were instructed to contact the CareFusion Support Center at 1-800-562-6018. For questions regarding this recall call 858-617-4000.
Quantity in commerce: 600 units
Distribution: CA, FL, AZ, and TN
Product codes and lots: Lot Number 13016314

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2279-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2279-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-25

Product code FPA

K931550Class IIEz Administration SetY / cleared 1994-01-10

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)