FDAFDA · Food and drugs·Recall number Z-2025-2014
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
Published July 16, 2014 · Recall initiated: June 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- Distributed in the states of FL, NM, WA, WI, and TX.
- Lot
- Lot No. 14035485 14046894 14035458 14035457
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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