PlainRecalls
FDA Devices Moderate Class II Terminated

CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

Reported: February 27, 2013 Initiated: December 20, 2012 #Z-0832-2013

Product Description

CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.

Reason for Recall

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.

Details

Recalling Firm
Carefusion 303 Inc
Units Affected
5,050 units
Distribution
Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.. Recalled by Carefusion 303 Inc. Units affected: 5,050 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 27, 2013. Severity: Moderate. Recall number: Z-0832-2013.