Recall Z-0832-2013 ยท FPA Set, Administration, Intravascular
Carefusion 303 Inc
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.
| Date | Feb 15, 2013 (initiated Dec 20, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Carefusion sent an "URGENT: Medical Device Recall Notification" letter dated January 21, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to return all recalled product directly to the distributor from whom it was purchased immediately, complete and return the enclosed pre-addressed and postage paid mandatory Customer Recall Response Card and to contact your distributor directly, or call the Carefusion Support Center, if you have any questions. For questions Recall Related |
| Quantity | 5,050 units |
| Distribution | Nationwide Distribution including the states of AK, CA, CO, IL, MO, NV, NY, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882302 | IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 Y, Jul 12, 1988 |