Z-2025-2014Class II

SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894...

Name: Z-2025-2014 SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894...
Creator: CareFusion 303, Inc.
Published: 2014-06-17
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2014-06-17 / Terminated / root cause: labeling and UDI

FDA source

CareFusion 303, Inc. began a recall of SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458 on 2014-06-17. FDA classified it as Class II and gives the reason as "CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2025-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-17
Posted: 2014-07-09
Terminated: 2016-09-20
Recalling firm: CareFusion 303, Inc
Product: SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: A recall letter is dated 6/25/14 and will be sent out to customers who purchased the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip chamber. The letter informs the customers of the problems identified, potential risk, and actions to be taken. Customers are instructed to promptly complete and return the enclosed mandatory Customer Response Card to acknowledge the receipt of this communication and to expedite the corrective action process.
Quantity in commerce: 5,600 units
Distribution: Distributed in the states of FL, NM, WA, WI, and TX.
Product codes and lots: Lot No. 14035485 14046894 14035458 14035457

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2025-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2025-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-09

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)