Device product
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.
Z-0832-2013
Product summary
- Event
- Event 64204
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,050 units
- Official record key
device-enforcement:Z-0832-2013
Official wording
Reason: 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.
Code information: Lot number 12055225
Distribution pattern: Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT.
Derived failure modes
-
Unknown
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.