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Recall Observatory FDA recall evidence

Device product

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

Z-2025-2014

June 17, 2014

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 68608
Status
Terminated
Classification
Class II
Quantity
5,600 units
Official record key
device-enforcement:Z-2025-2014

Official wording

Reason: 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

Code information: Lot No. 14035485 14046894 14035458 14035457

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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