CareFusion 303, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2025-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458

Product Classification:

Class II

Date Initiated: June 17, 2014

Date Posted: July 16, 2014

Recall Number: Z-2025-2014

Event ID: 68608

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

Status: Terminated

Product Quantity: 5,600 units

Code Information:

Lot No. 14035485 14046894 14035458 14035457

Distribution Pattern:

Distributed in the states of FL, NM, WA, WI, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated