FDAClass IIFebruary 27, 2013

CareFusion SmartSite Gravity Blood Set recall

CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the…

Why was CareFusion SmartSite Gravity Blood Set recalled?

CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . The separation may be observed at priming or observed during use. If a separation between the drip chamber and tubing occurs, this could cause a delay in treatment.

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 number 12055225

Product
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the…
Recalling firm
Carefusion 303 Inc
Quantity
5,050 units
Distribution
Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
Recall date
February 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls