FDAClass IIOctober 2, 2013

SmartSite Low Sorbing Infusion Set recall

SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

Why was SmartSite Low Sorbing Infusion Set recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers 13015883 and 13025342.

Product
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Recalling firm
CareFusion 303, Inc.
Quantity
15860 units
Distribution
Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI
Recall date
October 2, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls