CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood product...
FDA Recall #Z-0832-2013 — Class II — December 20, 2012
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.
Recalling Firm
Carefusion 303 Inc — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5,050 units
Distribution
Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
Code Information
Lot number 12055225
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated