FDAFDA · Food and drugs·Recall number Z-2285-2013
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Published October 2, 2013 · Recall initiated: August 30, 2013
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, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 303, Inc.
- Distributor
- Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI
- Lot
- Lot Numbers 13015883 and 13025342.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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