FDA-Device2014-07-16Class II
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
CareFusion 303, Inc.
Hazard
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
Sold states
Distributed in the states of FL, NM, WA, WI, and TX.
Affected count
5,600 units
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2025-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief