Z-2285-2013Class II

SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set

Name: Z-2285-2013 SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set
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# 10015048. Intravascular administration set 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# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber". 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-2285-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Posted: 2013-09-26
Terminated: 2014-04-16
Recalling firm: CareFusion 303, Inc
Product: SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: A customer letter dated August 30, 2013 will be sent to customers to inform them that CareFusion is recalling the SmartSite Low Sorbing Infusion Set Models 10015048, Lot Numbers 130153883 and 13025342 as a result of a potential for separation at the tubing sleeve below the drip chamber.The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributor letter will also be sent to distributors on 8/30/13 to inform them of the problems identified and the actions to be taken. Distributors are instructed to contact the Customer Support Team, return customer response form, and they are instructed to contact the CareFusion Support Center at 1-800-562-6018 with any questions. .
Quantity in commerce: 15860 units
Distribution: Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI
Product codes and lots: Lot Numbers 13015883 and 13025342.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2285-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2285-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-26

Product code FPA

K944320Class IIVented/non-Vented Gemini Administration SetImed Corp. / cleared 1995-02-14

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)