Device product
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
Z-2025-2014
Product summary
- 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
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