FDAClass IIApril 23, 2014

SmartSite Extension Set recall

SmartSite Extension Set, Model No. 20029E, intravascular administration set.

Why was SmartSite Extension Set recalled?

Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.

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 No. 13085791

Product
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Recalling firm
CareFusion 303, Inc.
Quantity
7,700 units
Distribution
USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI
Recall date
April 23, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls