FDA-Device2013-02-27Class II

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.

Carefusion 303 Inc
Hazard

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.

Sold states
Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
Affected count
5,050 units
Manufactured in
3750 Torrey View Ct, N/A, San Diego, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0832-2013

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